Principal Biostatistician Medical Affairs (Europe Only)

Syneos Health

8-12 years

preferred by company

10 Feb. 6, 2026

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Biostatistician – Medical Affairs (Europe Only)

Updated: February 3, 2026
Location: London, England, United Kingdom
Job ID: 25103959
Eligible Locations: United Kingdom, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, Netherlands
Employment Type: Full-time
Company: Syneos Health®

Job Overview

Syneos Health®, a globally integrated biopharmaceutical solutions organization, is seeking an experienced Principal Biostatistician – Medical Affairs to support clinical and medical affairs programs across Europe. This senior-level role plays a critical part in delivering high-quality statistical leadership throughout the clinical trial lifecycle, supporting regulatory submissions, medical publications, and evidence generation initiatives.

This position requires strong expertise in clinical trials, statistical analysis, and cross-functional collaboration within a global Medical Affairs environment.

Key Responsibilities

Provide end-to-end statistical leadership across assigned projects, from protocol development through Clinical Study Reports (CSRs).
Develop and author Statistical Analysis Plans (SAPs), including high-quality mock shell tables, listings, and figures.
Lead statistical contributions to protocols, randomization schedules, publications, and clinical study documentation.
Coordinate and oversee biostatistics and statistical programming activities to ensure timely, accurate, and compliant deliverables.
Review and approve programming specifications for analysis datasets and outputs.
Review annotated CRFs, database designs, and study documentation to ensure data integrity and analysis readiness.
Perform verification and quality control of statistical outputs in alignment with SAPs and regulatory standards.
Serve as the biostatistics representative on cross-functional project teams and internal governance meetings.
Manage multiple projects simultaneously, proactively addressing timelines, risks, and resource constraints.
Support integrated analyses, regulatory interactions, and responses to health authority queries when required.
Participate in Data Monitoring Committees (DMCs) or Data Safety Monitoring Boards (DSMBs), including charter development.
Ensure compliance with SOPs, Work Instructions, and regulatory guidelines including ICH and GCP.
Maintain inspection-ready documentation and contribute to audit preparedness.
Support business development activities, including proposals, budgets, and sponsor bid defense meetings.
Mentor and coach junior biostatistics staff and contribute to team capability development.
Provide statistical programming support as needed.
Perform additional duties aligned with business and project requirements.
Minimal travel may be required.

Required Qualifications and Experience

Education: Master’s or PhD in Biostatistics, Statistics, Mathematics, or a related scientific discipline.
Experience:
- Minimum 8–12 years of biostatistics experience within clinical trials, pharmaceutical, biotech, or CRO environments.
- Prior experience supporting clinical trials is mandatory.
- Demonstrated experience across Phase I–IV clinical studies.
Strong expertise in SAP development, clinical trial analysis, and regulatory documentation.
Proficiency in SAS and statistical programming methodologies.
Solid understanding of ICH, GCP, and global regulatory requirements.
Proven ability to manage complex projects and lead cross-functional teams.
Excellent written and verbal communication skills in English.
CV submission must be in English.

Why Join Syneos Health?

At Syneos Health, every role contributes to improving patient outcomes worldwide. Over the past five years, the organization has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, working across more than 200 studies, 73,000 sites, and 675,000+ clinical trial patients globally.

Employees benefit from:

Structured career development and progression pathways
Therapeutic and technical training programs
A supportive, inclusive, and diverse workplace culture
A Total Self philosophy that values authenticity and well-being
Opportunities to work on high-impact global clinical programs

Additional Information

This job description is not exhaustive and may evolve based on business needs. Syneos Health is an equal opportunity employer and is committed to providing reasonable accommodations in compliance with applicable laws. Equivalent experience and qualifications may be considered.

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Principal Biostatistician Medical Affairs (Europe Only)

Job Description

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