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Principal Biostatistician Fsp

6+ 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: Principal Biostatistician FSP
Location: Remote (United Kingdom, Germany, France, Spain)
Job Type: Full-time
Posted: Feb. 4, 2025
Job ID: 415

Job Overview:

As a Principal Biostatistician at Cytel, you will be dedicated to a major pharmaceutical client, providing statistical leadership and expertise in the development and analysis of clinical trials, with a particular focus on late-phase studies and regulatory submissions. You will leverage your experience in drug development, especially within Gastrointestinal studies, to drive clinical innovation and support the development of new treatments.

Responsibilities:

  • Lead statistical teams on clinical development projects, ensuring timely delivery of statistical output aligned with project goals.

  • Provide statistical input into clinical development plans, protocols, case report forms (CRFs), and data management plans.

  • Contribute to the preparation of statistical analysis plans (SAPs), perform statistical analyses, and review regulatory submission dossiers.

  • Manage biostatisticians and statistical programmers on a project, guiding the team on statistical strategy, deliverables, and processes.

  • Collaborate with cross-functional teams to ensure project goals are met, including working closely with regulatory authorities for electronic submissions.

  • Develop sourcing strategies for projects and maintain strong communication with sponsor biostatistics management.

Qualifications:

  • Education: Master’s degree in Statistics or related discipline (Ph.D. strongly preferred).

  • Experience: 6+ years supporting clinical trials in the pharmaceutical or biotechnology industry.

  • At least 3 years of recent experience with late-phase (II & III) drug development, including drafting SAPs, calculating sample size, and reviewing TLFs.

  • Experience with Gastrointestinal studies or regulatory submissions is a plus.

  • Strong SAS and/or R programming skills for QCing critical outputs, efficacy/safety tables, and collaborating with programmers.

  • Leadership experience in managing biostatisticians and statistical programmers.

  • Ability to work independently, innovate, and provide leadership in a team environment.

  • Excellent interpersonal, communication, and collaboration skills.

Additional Information:

  • Location: Remote work available in the United Kingdom, Germany, France, or Spain.

  • Cytel offers opportunities for professional development and growth, fostering an innovative work environment.

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