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Senior Statistical Programmer Fsp

Cytel
Cytel
7+ years
Not Disclosed
10 Feb. 17, 2025
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

Job Title: Senior Statistical Programmer FSP
Location: Remote  United Kingdom
Job Type: Full-time
Posted: Feb. 11, 2025
Job ID: 324

Position Overview:

As a Senior Statistical Programmer, you will be embedded with a global pharmaceutical client, contributing to the development of innovative treatments. You will lead or support Phase I-IV clinical trials, utilizing advanced SAS programming and applying CDISC standards (SDTM & ADaM). The position offers flexibility for remote work across several European locations.

Responsibilities:

  • Perform data manipulation, analysis, and reporting of clinical trial data, focusing on both safety and efficacy (ISS/ISE), using SAS programming.

  • Generate and validate SDTM and ADaM datasets, as well as tables, listings, and figures (TLFs).

  • Handle production and QC/validation programming, and generate complex ad-hoc reports using raw data.

  • Apply a deep understanding of efficacy analysis.

  • Create and review submission documents and eCRTs.

  • Serve as the primary point of contact for internal teams and clients on project specifications, status, and issues.

  • Lead programming tasks when needed, and collaborate with global teams to meet project goals and deadlines.

  • Adapt to changing priorities and contribute to team success.

Qualifications:

  • Education: Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field.

  • Experience:

    • At least 8 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry (or 6+ years with a master’s degree).

    • Experience leading studies, especially managing multiple projects.

    • Strong SAS programming, data manipulation, and reporting skills.

    • Solid experience with CDISC SDTM and ADaM standards.

    • Experience with ad-hoc reporting and efficacy analysis.

    • Familiarity with the drug development life cycle and submission document experience (e.g., define.xml).

    • Experience in immunology, respiratory, or oncology studies is a plus.

    • Ability to provide high-quality deliverables under tight timelines.

    • Ability to work effectively in a globally distributed team.

Additional Information:

  • Location: Remote work available in the UK

  • Cytel promotes professional growth through training and development, fostering an innovative work environment.