Advance Your Life Sciences Career
Make an Impact in Life Sciences
Vita Global Sciences (VGS), a Kelly Company, is a publicly traded Functional Service Provider (FSP) operating in highly regulated industries. Through established MSA contracts, we directly support some of the world’s top pharmaceutical and biotech companies. Our consultants contribute to critical functions across clinical research, biometrics, clinical data management, pharmacovigilance, regulatory affairs, and manufacturing operations—driving progress in complex, global life sciences programs.

Why join us?
VGS a Kelly Company is built to support high-performing experts who thrive in complex scientific environments. As part of our team, you will be embedded into one of our client’s functional teams, working across pre-clinical, clinical, post-marketing, or manufacturing phases. You will contribute directly to key milestones, using your expertise to support innovation and patient safety.
Each consultant is backed by a dedicated Kelly Manager with Functional expertise. This ensures clear communication, operational alignment, and access to the systems and processes you need to succeed in your role. You’ll be part of a global network that values scientific precision and operational integrity.
We specialise in:
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Clinical Operations
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Data Management
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Biometrics & Statistical Programming
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Pharmacovigilance & Safety
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Regulatory Affairs
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Medical Writing
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Discovery & Post-Approval Research
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Manufacturing Operations

Benefits of Joining VGS a Kelly Company
Global Reach
Continuous Learning
Client Integration
Dedicated Support
Life Balance
VGS a Kelly Company by the Numbers
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0+35,000 professionals on assignment globally
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08,500+ specialists in clinical research and science
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015,000+ R&D professionals
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012+ global FSP programs across 3+ continents
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$ 0 B$4.3B global revenue annually
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0 YRSBacked by over 75 years of staffing and consultancy expertise.
What Our Consultants Say
Annamalai Matchakkalai
Regulatory Affairs Specialist
Milena Dipalo
Regulatory Affairs Specialist
Fotios Xintaropoulos
Regulatory Affairs Specialist
"I truly value the professionalism and support I've experienced working with VGS a Kelly Company.
This trust has allowed me to focus on meaningful regulatory work and approach it with confidence and impact."
Michal Arad
Regulatory Affairs Specialist
Ekaterina Verenich
Regulatory Affairs Specialist
Łukasz Lechocki
Senior Regulatory Information Specialist
Chorouk Moenes
Regulatory Affairs Specialist
Cristina Pita
Regulatory Affairs Specialist
Open Positions
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Location: Strong preference for Dubai-based candidates, though applications from other Gulf states are welcome
Contract: 12 months with possible extension
We are recruiting Clinical Site Lead for our client, a prestigious and innovative MedTech leader transforming healthcare across the Gulf region! If you thrive in dynamic environments and have a passion for advancing clinical research in medical devices, this opportunity is for you.
Key Responsibilities
- Spearhead clinical study start-up and ongoing study actions for groundbreaking medical device trials.
- Serve as a vital bridge between the local hospitals, regulatory/ethics committees, and a supportive in-house submissions team.
- Lead hospital trainings, monitoring site activities, ensuring compliance with IRB requirements and study contracts.
- Deliver coverage in newly expanded geographic areas.
- Travel up to 30% throughout the Gulf region, with remote work flexibility and occasional office visits in Dubai.
Requirements
- Strong experience in clinical research, ideally as a Senior CRA or Clinical Site Lead, preferably within the medical devices sector.
- Fluent in English and Arabic; ready and able to travel widely across the Gulf.
- Skilled in IRB procedures, study contract management, and hands-on clinical site operations.
- Demonstrates energy, versatility, and creative problem-solving—able to manage diverse, concurrent projects and keep pace with an ambitious team.
If you’re seeking a meaningful, visible role at the forefront of medical device innovation, we want to hear from you!
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Contract: 12 months with possible extension
Location: Oberdorf, Switzerland (On-site mainly with some flexibility)
Our client, a global leader in the medical device industry, is seeking a motivated Test Technician / Test Specialist to join their product testing and verification team in Switzerland. This role offers an exciting opportunity to work hands-on with cutting-edge medical technologies while collaborating closely with experienced engineers in a highly regulated environment.
Ideal for professionals looking to advance in roles such as Product Test Engineer, Verification & Validation (V&V) Engineer, or Mechanical Test Engineer, this position provides exposure to innovative testing methods, ISO/FDA compliance, and product lifecycle development.
Key Responsibilities
- Plan, coordinate, prepare, and execute recurring mechanical product tests in collaboration with Senior Test Engineers.
- Conduct routine and complex testing activities independently, ensuring accuracy and adherence to SOPs, ISO, and FDA requirements.
- Evaluate and interpret test results, prepare test protocols, reports, and enter data into IT/LIMS systems.
- Support the development and validation of new test methods and contribute to the creation of standard operating procedures (SOPs).
- Maintain and update test instructions and documentation within the document management system.
- Collaborate effectively with internal and external clients to meet testing deliverables and timelines.
- Ensure full regulatory compliance and participate in continuous improvement initiatives to optimize testing efficiency.
Profile & Qualifications
- Completed apprenticeship (e.g., Polymechanic, Laboratory Technician) with 1–2 years of experience in product testing or
- a Bachelor’s/Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
- Prior experience in product testing, verification & validation, or medical device testing strongly preferred.
- Knowledge of ISO 13485, ISO 14155, or FDA 21 CFR Part 820 is a strong plus.
- Strong organizational skills, attention to detail, and initiative.
- Excellent written and verbal communication skills (English required; German or French an advantage).
- Proactive team player with a hands-on attitude and the ability to adapt in a dynamic environment.
What’s Offered
- Opportunity to work for a global leader in medical technology, with exposure to high-impact products.
- Full benefits and competitive remuneration package.
- Professional development and hands-on training in product verification, validation, and testing.
- Collaborative and innovative team environment.
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Location: Colombia or Peru
Contract: 12 months with possible extension
Overview
Join KellyOCG as a Business Process Analyst in Regulatory Affairs. The role’s objective is to drive continuous improvement and digital transformation in the planning and budgeting processes of the Latin America Regulatory Affairs area, ensuring efficient data integration and automation of critical tasks. The position requires a combination of technical expertise in analytical and automation tools, along with skills to lead optimization projects and collaborate with cross-functional teams in a regional and global corporate environment.
Main Responsibilitie
- Support in the preparation of reports and data collection for the Submission Planning and Work Plan process of the Regional Regulatory Affairs area.
- Develop analytical solutions and automations that optimize decision-making.
- Provide ongoing support in the improvement of regulatory planning and budgeting processes for the Latin America Regulatory Affairs area through the development of technological tools and improvements to those already in place.
- Collaborate in the technical implementation of dashboards and metrics designed to monitor planning and budgeting processes for the Regional Regulatory Affairs area. Ensure the development of tools and techniques for the automatic generation, at defined frequencies, of such metrics.
- Assist in identifying and implementing transformative improvements in the processes, tools, and systems used by the area, aiming for continuous improvement and increased efficiency. Examples include, but are not limited to:
- Automating manual processes with Power Automate flows to reduce time and errors.
- Integrating data across platforms (Smartsheet, SharePoint, Dataverse) to ensure consistency and traceability.
- Optimizing analytical models in Power BI by applying best practices in modeling and performance.
- Developing applications in Power Apps to centralize information management and facilitate decision-making.
- Implementing simple ETLs (Extract, Transform, Load) in Python for cleaning and validating data from multiple sources.
Technical Skills
Advanced Excel (required):
- Advanced formulas: XLOOKUP, INDEX/MATCH, LET, LAMBDA
- Use of Power Query (M language)
- Analytical models, pivot tables, and scenarios
Power BI (required):
- Languages: DAX, Power Query M, basic–intermediate SQL
- Data modeling, star schema design and relationships
- Data cleaning and transformation from multiple sources
- Integration with SharePoint, Smartsheet, Excel, Dataverse
- Model and performance optimization
Power Automate (required):
- Languages and structures: Expressions, JSON, REST APIs
- End-to-end flow design
- Integrations with Power Apps, Smartsheet, SharePoint
- Handling variables, conditions, loops, and connectors
- Automation of approvals, notifications, and critical processes
Power Apps (Canvas Apps) (required):
- Language: Power Fx
- Creating applications connected to SharePoint, Excel, Smartsheet, Dataverse
- Managing collections, forms, business logic, and “patch” function
- Building functional and efficient interfaces in Power Apps
Soft Skills:
- Effective communication: Ability to clearly convey technical and strategic information to cross-functional teams and stakeholders.
- Analytical thinking and problem-solving: Skill to identify opportunities for improvement and propose innovative, data-driven solutions.
- Time management and organization: Prioritize tasks and meet deadlines on complex, simultaneous projects.
- Collaboration and teamwork: Work with regional teams, promoting cooperation and sharing best practices.
- Adaptability and continuous learning: Adjust to changes in processes, tools, and priorities in a dynamic environment.
- Results-oriented: Focus on delivering solutions that provide tangible impact in efficiency and quality.
- Ability to coordinate improvement initiatives and motivate teams toward common goals.
Additional Requirements:
- Spanish language (oral and written), advanced level.
- Mandatory: Advanced command of English (oral and written), for interaction with global teams and technical documentation.
Not mandatory: Portuguese language (oral and written).
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Location: Bogota, Colombia or Lima, Peru (on site)
Contract: 12 months with possible extension
Overview:
As an Ariba & Legal Documentation Support Specialist, where you'll play a pivotal role in managing payments process and management of legal documentation activities. If you are detail-oriented and proactive, this remote LATAM opportunity will allow you to support smooth purchasing operations, E2E payment process and management of Legal Documentation Database of the area, ensuring compliance and efficiency throughout our organization.
Key Responsibilities:
Ariba Procurement Support:
- Manage RA-PAY processes for Consultants, MoH Fees, Other payments, and aCREW within the Ariba system.
- Assist in the creation, processing, and tracking of purchase requests and orders.
- Help users navigate the Ariba platform, provide troubleshooting, and respond to inquiries.
- Ensure procurement documents are complete, accurate, and compliant with company policies.
- Coordinate with suppliers, internal stakeholders, and procurement colleagues for timely and correct order fulfillment.
- Maintain and update procurement records and related data in Ariba.
- Reference and utilize "VOLUMEN Servicios" spreadsheet for accurate service details.
- Notify points of contact regarding approvals and any inconsistencies.
- Review and register invoices for accuracy.
- Create payment requests in EMP, register payment dates, and upload proof of payment.
- Send email communication to requesters for aCREW answers; close positions in the aCREW system.
Legal Documentation Support:
- Assist with the preparation, review, organization, and management of legal documents such as contracts, agreements, amendments, and confidentiality agreements.
- Support the reception of physical and electronic legal files.
- Send emails to local teams to inform them of the arrival of new documents and update the repository accordingly.
- Make documentation information available and update the repository with arrival TN, date, country of destination, location, codes, description, manufacturers, document type, apostilled or not, translated or not, and number of copies; keep all details up to date.
- Track contract statuses, deadlines, renewals, and ensure proper execution and filing in accordance with company procedures.
- Coordinate with legal, compliance, and business teams to gather necessary information and ensure documentation accuracy.
- Help communicate contract requirements, obligations, and timelines to relevant stakeholders.
- Maintain contract databases and support document management systems for legal documentation.
- Manage the shipping of legal documentation to other countries and confirm document arrivals.
- Expiration management: Eliminate expired documents both from storage and the code database to keep the repository current and compliant.
Compliance & Process Improvement:
- Monitor adherence to procurement and legal processes, escalating issues when needed.
- Identify and suggest improvements to documentation, workflow, and compliance procedures.
Requirements:
- Degree in Business Administration, Law, Procurement, or related field.
- Prior experience or keen interest in procurement operations and/or legal documentation management.
- Familiarity with Ariba or other payment platforms is preferred.
- Excellent attention to detail and organizational skills.
- Strong written and verbal communication skills.
- Ability to work collaboratively with cross-functional teams.
- Proficiency in MS Office and document management tools.
Nice to Have:
- Experience working in corporate legal or procurement teams.
- Knowledge of contract lifecycle management systems.
- Understanding of compliance requirements in procurement and legal documentation.
- Additional language skills.
Why KellyOCG?
Be part of a globally recognized company with a culture of integrity, collaboration, and continuous improvement. You'll have opportunities for professional development and growth while contributing directly to the success of our procurement and legal operations.
Apply now to join our team and make an impact!
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Location: Colombia or Peru
Contract: 12 months with possible extension
Summary
We are seeking a resourceful and detail-oriented MDRIM & GTS Data Analyst to support regulatory operations by ensuring the accuracy and timeliness of MDRIM and GTS updates. The successful candidate will work closely with both local and regional teams, maintaining regulatory systems and communicating important updates to stakeholders.
Key Responsibilities
- Regularly update MDRIM reports (open the application and ensure data is current).
- Upload documents to SharePoint (SP) and send notification emails.
- Maintain MDRIM system according to local and regional requests.
- Manage code inclusion, inactivation, or removal in MDRIM, as required by regulatory needs.
- Update License Dashboard to reflect current licensing status.
- Communicate approvals to distribution lists in accordance with the process.
- Update ESD (Export Shipping Document) and DRD (Document Review Document) within designated templates.
- Update SEP (Shipping Export Permit) records as needed.
- Follow up on MDRIM updates in collaboration with the local team and ensure timely completion.
Qualifications
- Bachelor’s degree in Science, Business, Information Systems, or a related field.
- Work experience with data management, document handling, and reporting tools; familiarity with MDRIM and GTS systems is an advantage.
- Proficient in Microsoft Excel, SharePoint, and other relevant applications.
- Excellent organizational skills and attention to detail.
- Strong communication abilities to interface with local, regional, and cross-functional teams.
- Ability to manage multiple priorities effectively and meet deadlines.
Desirable Skills
- Experience in regulatory affairs, compliance, or document management.
- Analytical approach to process improvement and data quality assurance.
- Experience creating dashboards and reports for regulatory processes.
Why Join Us?
Become part of an innovative and collaborative team supporting global regulatory compliance. We offer dynamic work opportunities, skill development, and a professional environment dedicated to excellence.
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Location: Taguig, Philippines - Hybrid 3 days/week
Kelly FSP is seeking a skilled Area Safety Officer to join our client’s team. This opportunity is ideal for professionals who excel in compliance, risk management, and product vigilance at both local and global levels.
Key Responsibilities
· Serve as the Local Nominated Person for Pharmacovigilance, acting as the primary safety contact in accordance with national laws and regulations.
· Monitor and assess regulatory changes to maintain ongoing compliance.
· Liaise with internal teams, vendors, distributors, and third parties to reconcile safety data and report findings promptly.
· Oversee the identification and review of local literature for Adverse Event (AE) reporting, ensuring thorough document management and archiving.
· Prepare, submit, and manage safety reports (e.g., SAE, SUE, SUSARs, PSURs, RMPs) for health authorities and key stakeholders.
· Respond to health authority inquiries and notifications regarding safety concerns.
· Maintain comprehensive knowledge of local pharmacovigilance, cosmetic, and device vigilance requirements, adapting quickly to regulatory updates.
· Record and manage non-conformances, and work with global teams to develop and implement effective Corrective and Preventative Action (CAPA) plans.
· Deliver specialized training on safety reporting and best practices to local staff.
· Translate safety documents as required for local and international teams.
· Develop, update, and implement procedures in alignment with global and local standards.
· Support audits and inspections by health authorities, and contribute to business continuity planning.
Additional Responsibilities
· Draft and provide pharmacovigilance clauses for inclusion in local contracts and agreements.
· Undertake additional duties as assigned by management.
Qualifications
· Degree in a healthcare-related field (e.g. nursing, pharmacy, life sciences) or equivalent experience and training.
· 2 years of relevant experience in the pharmaceutical industry, ideally with a focus on product vigilance.
· Strong foundation in medicine, pharmacy, clinical practice, or related science disciplines.
· Excellent understanding of medical terminology.
· Tech-savvy with solid IT and computer skills.
· Proficient in both local language(s) and English.
· Exceptional verbal and written communication skills.
· Collaborative team player, able to build productive relationships internally and externally.
Why Join Us? This is an exciting opportunity to make a tangible impact on public health and work with a team dedicated to safety and regulatory excellence. If you have a passion for compliance and pharmacovigilance, apply today and advance your career with us!
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Location: Issy-les-Moulineaux, France (Hybrid)
Contract: 12 months
Kelly FSP is looking for a skilled Senior Area Safety Officer to join our client's team and drive compliance, risk management, and product vigilance across local, regional, and global levels.
Your Impact:
- Ensure compliance with safety regulations and internal policies.
- Oversee product vigilance and risk management systems for all products.
- Collaborate with global and local teams to deliver vigilance activities and respond to safety queries.
- Support health authority inspections, audits, and business continuity planning.
- Contribute to the ongoing development and improvement of safety data and procedural documentation.
What You’ll Do:
- Provide oversight of vendor resources and vigilance activities in scope countries.
- Advise on updates to system master files and develop corrective actions for non-conformances.
- Maintain thorough reporting and documentation practices.
- Help train and maintain awareness of safety protocols for local teams.
- Stay up-to-date on evolving safety regulations, supporting implementation of new requirements.
- Translate and manage safety documents as needed.
- Develop and update local procedures, ensuring alignment with global standards.
- Support inspections, audits, and business continuity planning for vigilance operations.
- Back-up the Area Safety Head as required.
Who You Are:
- A health care science professional (e.g., pharmacist, nurse) with at least 3 years’ experience in pharmaceutical safety.
- Experienced in product vigilance roles within the pharmaceutical industry.
- Able to work autonomously and organize workflow efficiently.
- Knowledgeable on regulations and principles of pharmacovigilance, drug development, and product safety.
- Skilled in relevant IT safety systems; fluent in English with excellent communication skills.
- Proven collaborator, able to maintain strong relationships within the organization and with regulatory authorities.
This is your chance to make a meaningful difference in a dynamic and collaborative environment.
Ready for the next step in your pharmacovigilance career? Apply now and join us in promoting product safety and public health!
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Location: Mexico
Contract: 12 months with possible extension
Key Job Activities:
Under direction of Clinical Operations personnel, and in accordance with all applicable Regional, state and local laws/regulations and corporate procedures and guidelines, this position will:
- As directed, provides support to the project teams which may include tracking study data, following-up with clinical sites on essential documents; assist in drafting and distributing study mailings, including study newsletters; assist in drafting of agenda/meeting minutes and scheduling of meetings.
- Assist in payments/tracking for patient reimbursements.
- Performs data entry in systems
- Run reports including training matrix reports, metrics for management reviews
- Support management of IRB/IEC renewal compliance.
- Coordinate process for the review of study data, such as MRIs, by third-party vendors.
- Assist in ordering, shipping, tracking of, study supplies including, but not limited to, investigational devices and site binders. Maintain master device accountability log as requested
- Assist with scheduling and organizing investigators and expert panel meetings.
- Assist with file reviews and Audit preparation
- Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members.
- Work with management group to help achieve department goals.
- Participate in process improvement activities within the department.
- May be involved in other tasks to support Clinical Operations and Operating Company as needed.
- Other Administrative Tasks
Job Qualifications
- Minimum of a Bachelor’s Degree is required.
- Previous clinical research experience – highly preferred
- Requires previous administrative support experience or equivalent for at least 1 year.
- Clinical/medical background – highly preferred
- Requires experience and knowledge working with computer systems (Microsoft office –Excel, Word and Power Point).
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Location: Leeds, United Kingdom
Employment Type: 12 months Full-time, On-site (with some flexibility)
Our client, a global leader in the medical device industry, is seeking a motivated Test Technician / Test Specialist to join their product testing and verification team in Leeds. This is an exciting opportunity to work hands-on with cutting-edge medical technologies, collaborating closely with experienced engineers and scientists in a highly regulated, innovative environment.
This position is ideal for professionals aiming to advance toward roles such as Product Test Engineer, Verification & Validation (V&V) Engineer, or Mechanical Test Engineer. It offers valuable exposure to product lifecycle development, ISO/FDA compliance, and computational modelling as part of the verification process.
Key Responsibilities
- Plan, coordinate, prepare, and execute mechanical product tests in collaboration with Senior Test Engineers.
- Conduct routine and complex mechanical and functional testing activities independently, ensuring adherence to SOPs, ISO standards, and FDA/UK regulatory requirements.
- Evaluate and interpret test data, prepare test protocols and reports, and maintain records within laboratory information management systems (LIMS).
- Support the development and validation of new test methods, and contribute to the creation and revision of standard operating procedures (SOPs).
- Utilise computational modelling and simulation tools to support test planning, data interpretation, and product performance prediction.
- Maintain and update test documentation within the document management system.
- Collaborate with R&D, Quality, and Manufacturing teams to ensure all testing deliverables meet project timelines and regulatory standards.
- Participate in continuous improvement initiatives, driving efficiency, accuracy, and innovation in the test environment.
Profile & Qualifications
- Completed apprenticeship (e.g. Mechanical / Laboratory Technician) or Bachelor’s/Master’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related discipline.
- 1–2 years of relevant experience in product testing, verification & validation (V&V), or medical device testing.
- Hands-on experience with mechanical testing equipment, measurement tools, and data acquisition systems.
- Exposure to or interest in computational modelling (e.g., FEA, CFD, or other simulation tools) is strongly preferred.
- Working knowledge of ISO 13485, ISO 14155, or FDA 21 CFR Part 820 standards is an advantage.
- Strong attention to detail, analytical thinking, and problem-solving skills.
- Excellent written and verbal communication skills in English.
- Proactive, team-oriented mindset with the ability to work effectively in a fast-paced and regulated environment.
What’s Offered
- Opportunity to work for a world-class medical technology company developing life-changing products.
- Competitive salary and comprehensive benefits package.
- Professional development opportunities and hands-on training in verification, validation, and computational modelling.
- Collaborative, inclusive, and innovation-driven culture with a focus on quality and continuous improvement.
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Location: Zaventem, Belgium
Contract: 12 months with possible extension (Start from March-April 2026)
Kelly FSP is seeking a Clinical Submission Specialist to support one of the world's top five pharmaceutical companies in the medical devices sector. This role involves coordinating and preparing regulatory submissions to ensure compliance with global regulatory requirements for medical devices.
Key Responsibilities:
- Prepare and submit documents for EC/CA in the assigned region.
- Initiate and review translations of documents (e.g., Patient Informed Consent).
- Adapt Country/Site Specific Patient Informed Consent forms according to regulatory and EC requirements and obtain internal approval.
- Interpret clinical study protocols for EC/CA submission using layman terms where necessary.
- Act as the primary point of contact for EC/CA.
- Support document adaption per EC/CA requirements and manage responses.
- Assist in budget adaptation to meet country and site requirements.
- Maintain local regulatory documents and ensure they are uploaded to data management systems where applicable.
- Provide support to CSL and Clinical Project Teams.
- Assist in developing and reviewing informed consent documents to ensure all required elements are included.
- Support site activation document collection and approval processes.
- Attend, schedule, and document project-related meetings.
- De-identify and file adverse event source documents if applicable.
- Maintain the Clinical email box and disseminate emails appropriately.
- Support team personnel with site activation and closure activities.
Qualifications:
- 3-7 years of clinical submission experience across multiple EMEA regions.
- Must be familiar with submission processes across EMEA countries (Southern Africa, Israel, Eastern Europe are a plus).
- Effective phone communication skills are essential; candidates must be comfortable managing calls with authorities.
- Proficiency in English is required.
- Familiarity with cardiac, vascular, and/or neuromodulation technologies and clinical research processes is beneficial.
- Strong verbal, written communication, and interpersonal skills.
- Ability to work in a fast-paced, changing environment and within a geographically diverse business model.
- Strong organizational skills and ability to prioritize tasks to meet deadlines.
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Location: EU remote
Contract: 12 months with possible extension
Are you ready to take your statistical programming career to the next level? Join us as a Principal Statistical Programmer where you’ll play a key technical and strategic role across multiple clinical studies and post-marketing projects. You'll work hands-on with advanced analytical techniques, lead programming efforts, and collaborate with cross-functional industry leaders to deliver high-quality results that support patient safety, drug efficacy, and regulatory success.
What You'll Do
· Lead Statistical Programming: Be the main programming expert for assigned studies, working closely with sponsors and internal teams to drive project success.
· Develop Reliable Analyses: Create and validate SAS programs for analysis datasets (ADaM), tables, listings, and figures that underpin clinical study reports, interim analyses, and exploratory data reviews.
· Champion Quality and Compliance: Review and oversee statistical deliverables from external partners to ensure accuracy and regulatory alignment.
· Shape Regulatory Submissions: Prepare submission-ready documentation (define.xml, annotated CRFs, Reviewer’s Guides), and collaborate on pooled analyses for integrated safety & efficacy summaries.
· Collaborate and Communicate: Work alongside biostatistics, data management, and medical writing teams to meet project timelines and deliverables.
· Promote Process Improvement: Streamline and automate workflows using tools like R, Python, or metadata frameworks.
· Mentor and Inspire: Support junior programmers, fostering growth in statistical programming and data analytics.
· Ensure Audit Readiness: Maintain top-quality documentation and compliance with industry standards and best practices.
Who You Are
· Experienced Programmer: Master’s degree (7+ years) or Bachelor’s (9+ years) in Statistics, Computer Science, or a related field, with hands-on experience in clinical trial statistical programming.
· CDISC Expert: Deep knowledge of SDTM and ADaM standards and submission processes.
· Analytical Leader: Proven ability to handle ad-hoc and exploratory analyses, and support publication and regulatory responses.
· Collaborator: Strong communication skills and experience leading projects and managing deliverables from external providers.
· Tech-Savvy: Experience with Pinnacle 21, Define.xml, and data visualization platforms (Spotfire, R Shiny) is a plus.
· Innovator: Familiarity with R or Python for automation and statistical programming is highly desirable.
Why Apply?
Here, you’ll have the chance to make a meaningful impact, mentor others, and innovate in a dynamic and supportive environment. If you’re ready to lead, collaborate, and help shape the future of clinical research, we want to hear from you!
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Location: EU remote
Contract: 12 month with possible extension
Are you passionate about transforming clinical data into meaningful insights? Join our team as a Senior Statistical Programmer, where you’ll take an active role in delivering programming solutions that drive successful clinical studies and regulatory submissions. You’ll collaborate with leading biostatisticians, CRO partners, and project teams, using your technical expertise to ensure accuracy, compliance, and excellence in every deliverable.
What You'll Do
· Develop & Validate Clinical Programs: Create and maintain robust SAS programs to generate high-quality datasets, tables, listings, and figures (TLFs) for clinical studies, always meeting timelines.
· Ensure Data Quality: Validate and QC all datasets and outputs to guarantee compliance with regulatory standards—accuracy, consistency, and traceability are key!
· Work with Industry Standards: Apply your knowledge of CDISC SDTM and ADaM mapping, including using Pinnacle 21 validation, for regulatory submissions.
· Support Study Documentation: Review protocols, CRFs, SAPs, and mapping specifications to fully understand study objectives and analysis plans.
· Collaborate: Partner closely with biostatisticians and cross-functional teams to align analyses and troubleshoot data issues for smooth study progress.
· Mentor & Guide: Share your expertise with junior programmers and help foster a culture of learning and best practices.
· Handle Complex Outputs: Tackling dynamic reporting, ad-hoc analyses, and advanced statistical logic will be part of your everyday.
· Drive Submission Readiness: Prepare and review key submission documents such as define.xml, annotated CRFs, and reviewer guides for regulatory compliance.
· Deliver Excellence Under Pressure: Manage multiple tasks, prioritize effectively, and consistently deliver high-quality work—even in fast-paced environments.
· Promote Standardization & Improvement: Champion process enhancements, standard procedures, and the use of the latest tools in programming, automation, and data visualization.
Who You Are
· Experienced Programmer: Master’s degree (5+ years) or Bachelor’s (7+ years) in Statistics, Computer Science, or related field, with strong FSP engagement experience.
· Clinical Data Expert: Skilled in statistical programming, data manipulation, reporting, and analysis for clinical trials.
· CDISC Standards Champion: Solid knowledge of SDTM and ADaM, plus experience with Pinnacle 21, define.xml tools, and eCTD submissions.
· Problem-Solver: Organized, proactive, and able to manage multiple priorities independently.
· Team Player: Excellent communicator who thrives in collaborative environments, but also excels working autonomously.
· Innovator: Exposure to programming automation, visualization, or metadata-driven tools such as R, Python, or Spotfire is a plus.
Ready to make a real difference in clinical research? Apply now and help us deliver the data that powers tomorrow’s breakthroughs!
FAQs
Got questions about working with VGS a Kelly Company? Here’s a quick guide to help you understand our process, contracts, benefits, and the support you can expect throughout your journey.
What is VGS a Kelly Company?
VGS/Kelly FSPVGS a Kelly Company is a global public organization specializing in consulting and recruitment across the US, EMEA, and APAC. VGS a Kelly Company focuses on outsourcing talent to top life science clients globally, covering roles in clinical research, data management, biostatistics, pharmacovigilance, regulatory, and more.
What makes VGS a Kelly Company a great place to work?
We connect professionals with leading pharma, biotech, and medical device companies. You gain exposure to global projects, access client systems, and benefit from training and development support from our Functional Managers and Talent Care Team.
What contract types does VGS a Kelly Company offer?
We provide both freelance and employment contracts, depending on client needs and assignment type. Contracts comply with local labor laws via VGS a Kelly Company entities or trusted payroll partners. We also help with visa support when needed.
Will I receive benefits?
Yes, our benefits are aligned with local country standards and contract type. Specific details will be discussed during the interview and offer process. You are encouraged to share your preferences or questions with our Talent Acquisition and HR teams, who can provide tailored information and support.
How does the hiring process work?
Our process includes:
1. Interview with VGS a Kelly Company
2. Interview prep with our TA team
3. Client interviews (usually 1–3 rounds)
4. Offer & onboarding via Kelly
5. Ongoing assignment support
What is VGS a Kelly Company's relationship with the end client?
We are proud to serve as long-term, preferred partners to leading life science companies, operating under global agreements and supporting hiring managers across the US, EMEA, and APAC regions.
We support both large multinationals and medium-sized organizations. While your employment contract will be with VGS, a Kelly Company, you will functionally operate as an integral part of the client’s team, following their SOPs and utilizing their systems.
What happens after my assignment ends?
While a second assignment is not guaranteed, we aim to redeploy qualified professionals to new projects. If the client is interested, they may hire you directly after your assignment ends.
What if I don’t hear back after an interview?
We always strive to provide feedback. If you haven’t heard back within 2 weeks, please reach out to your VGS a Kelly Company recruitment consultant.