Jobs in Bedford, United Kingdom

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Lead Statistical Programmer – Sponsor Dedicated
Location: Maidenhead (100% home-based in EMEA or office-based in home country)
Category: Clinical
Job ID: 253609

The Lead Statistical Programmer plays a central role in delivering complex clinical projects for a top global pharmaceutical sponsor. The role involves planning, executing, and overseeing all programming activities, liaising with cross-functional teams, mentoring junior programmers, and ensuring high-quality outputs aligned with regulatory and sponsor standards.

Programming Oversight

Plan, execute, and oversee all statistical programming activities for assigned studies.

Manage resources, work within budget, meet timelines, and maintain high-quality deliverables.

Supervise SDTM, ADaM, and TLF development and perform senior-level review of outputs.

Cross-Functional Collaboration

Liaise with Clinical, Medical Writing, Safety, and Biometrics teams.

Coordinate additional programming support for publications, medical writing, and analyses.

Support and oversee regulatory submission activities, particularly in late-phase studies.

Quality & Process Management

Ensure efficient execution of programming tasks with proper tools and macros.

Prioritize quality while adhering to departmental standards and processes.

Mentor less-experienced team members on SDTM, ADaM, and TFL best practices.

Promote adherence to programming standards and processes.

Degree in Mathematics, Life Sciences, Statistics, Computer Science, or equivalent experience in statistical programming within clinical trials.

Minimum 5 years of experience with complex clinical trials and corresponding datasets (safety and efficacy endpoints).

Previous lead experience preferred.

Expertise in base SAS, SAS macros, SAS/STAT, and debugging SAS programs.

Broad knowledge of CDISC standards (SDTM, ADaM), define.xml, Reviewer’s Guides, and submission requirements.

Fluent in English, both written and verbal.

Strong collaboration skills, autonomy, curiosity, and attention to detail.

Knowledge of end-to-end clinical trial processes and cross-functional team responsibilities (Biostatistics, Clinical Data Management).

Experience supporting regulatory submissions and publications.

Home-based or local office in EMEA.

Collaborative, global CRO setting with opportunities for career growth.

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