Director, Biostatistics

Position Summary

Reporting to the Vice President, Biometrics, the Director, Biostatistics will serve as a project-level biostatistician and provide leadership within the biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology. Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data.

Essential Job Functions And Responsibilities

• Provide strategic and technical leadership in biostatistics to support oncology clinical development programs and study execution
• Contribute to protocol development, ensure appropriate trial design, sample size determination, and efficient statistical methodologies
• Lead development of statistical analysis plans, data presentation plans, and biometrics components of clinical and regulatory strategies
• Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications
• Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
• Represent biostatistics function or biometrics department in cross function teams
• Work with department head to develop and implement department policies, standards and procedures
• Partner with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
• Participate in FDA and other health authorities to interactions to align on development strategies

Preferred Qualifications

• Master’s degree in statistics or biostatistics required, or a related area degree preferred (e.g., MS) with 10+ years of progressive clinical trial, or healthcare experience in the life sciences industry or an equivalent combination of academic and industry experience
• Technical expertise and knowledge of experimental design and analyses using SAS; Experience with R helpful
• In-depth knowledge of CDISC standards
• Solid working knowledge of ICH, FDA and GCP regulations and guidelines
• Experience in supporting oncology phase 1/2/3 clinical trials
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities