Biostatistician

Biostatistician – Oncology

The Biostatistician plays a vital role in the implementation and execution of methodological and statistical aspects of clinical studies under the supervision of a Therapeutic Area Lead Biostatistician or Project Lead Statistician. In some cases, this position may focus on developing or applying specialized expertise in a specific statistical area or application.

A Typical Day Might Include:

• Providing support to a clinical study team on all relevant statistical matters under the guidance of senior departmental staff.
• Ensuring the clinical study is conducted in a manner that aligns with planned statistical analyses.
• Participating in the preparation of study protocols and amendments, performing sample size calculations, and drafting statistical methodology sections for protocols.
• Reviewing case report forms (CRFs) and providing constructive feedback.
• Developing Statistical Analysis Plans (SAPs) and working collaboratively with the programming team to define and document derived variables for Tables, Figures, and Listings (TFLs).
• Performing statistical analyses in accordance with the SAP, validating analysis programs, and reviewing TFLs.
• Preparing statistical methods and results sections for Clinical Study Reports (CSRs), offering insights into study results, and supporting the CSR review and approval process.
• Contributing to project-related activities, including the preparation of BLA submissions and overseeing deliverables from Contract Research Organizations (CROs).

This Role Might Be for You If You Can:

• Collaborate effectively with multidisciplinary teams to support clinical study design and execution.
• Translate complex statistical concepts into clear, actionable deliverables.
• Manage competing priorities while maintaining high attention to detail.

Qualifications:

• A Master’s Degree in a related field.
• At least 2 years of relevant experience in biostatistics or a related area.