Senior Director, Biostatistics

Job Title: Senior Director, Biostatistics

Job Number: 36139

Location: , 

Job Description

Reporting to the Vice President of Biometrics, you will collaborate with cross-functional clinical teams overseeing statistical activities across clinical programs, including managing outsourced statistical deliverables with CROs. This role offers the opportunity to contribute to the development of transformative therapies. The ideal candidate is an effective communicator, collaborative, self-motivated, and forward-thinking.

Responsibilities

• Serve as a biostatistics expert for clinical programs, providing strategic input on trial designs
• Collaborate with internal and external teams on statistical deliverables and conduct statistical modeling
• Contribute to protocol development, oversee statistical analysis plans, and ensure eCRF designs align with statistical needs
• Perform QC/QA of results, support regulatory submissions, and address questions from regulatory agencies
• Contribute to publications and presentations, lead process improvements, and represent the company externally
• Support inspection readiness and maintain expertise in oncology statistics

Required Skills

• PhD in statistics or related field, or MS with relevant experience
• 12+ years in the pharmaceutical/biotech industry, with oncology experience
• Expertise in clinical trial design, analysis, and reporting
• Experience with INDs, NDAs, MAAs, and regulatory submissions
• Strong knowledge of statistical methods and clinical trial regulations (FDA, EMA, ICH)
• Proficient in SAS and R programming
• Ability to lead statistical efforts across multiple studies
• Fluent in SDTM and ADaM data standards
• Experience managing outsourced CRO statistical services
• Strong communication skills, with the ability to explain statistical concepts clearly