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Senior Biostatistician Fsp

Cytel
Cytel
5+ 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 Biostatistician FSP
Location: Remote, United Kingdom and South Africa
Job Type: Full-time
Posted: Dec. 30, 2024
Job ID: 141

Job Overview:

As a Senior Biostatistician, you will provide statistical support to clinical studies and collaborate with cross-functional teams to ensure the successful execution of clinical trials. You will play a key role in statistical analysis, study protocol development, and submission activities. The role involves applying advanced statistical methods to support Phase I-IV clinical trials and regulatory submissions.

Responsibilities:

  • Provide statistical support to clinical studies and participate in the development of study protocols.

  • Perform sample size calculations, protocol development, and statistical analysis plan (SAP) creation.

  • Review CRFs, develop statistical analysis plans, and create analysis dataset and TLG specifications.

  • Interpret statistical results and prepare clinical study reports, including integrated summaries for regulatory submissions.

  • Communicate statistical methodology and findings effectively to internal and external teams.

  • Collaborate with clinical and regulatory colleagues on FDA regulations and electronic submission guidelines.

  • Contribute to the development and maintenance of statistical programming standards.

  • Review and/or author SOPs and work instructions related to statistical programming.

Qualifications:

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

  • Experience: 5+ years supporting clinical trials in the pharmaceutical or biotechnology industry.

  • Skills:

    • Experience in sample size calculation, protocol development, SAP, and preparing clinical study reports.

    • Good SAS programming skills for QCing critical outputs and efficacy/safety tables.

    • Knowledge of R programming is a plus.

    • Solid understanding of CDISC standards for regulatory submissions.

    • Expertise in ADaM dataset generation and QC.

    • Strong communication skills to explain complex statistical concepts in lay terms.

Additional Information:

  • Location: Remote in the United Kingdom or South Africa.

  • Cytel encourages professional development and growth, offering an exciting opportunity to work with cutting-edge clinical development initiatives.

Apply Now