Director Biostatistics - Oncology

Our client is a clinical-stage biopharma company focusing in the Oncology space. They are currently seeking a highly skilled and experienced Director of Biostatistics to provide leadership to develop and execute statistical strategy, design and analyses for clinical trials in all phases. As Director you will apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.

This is onsite role based in the Bay Area.

About the Role:

• • • Provide leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
    • Apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
    • Develop and/or applies statistical theories, methods and software.
    • Partner in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
    • Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
    • Represent biostatistics function in interactions with institutional review boards, ethics committees, and health agencies.
    • Work with department head to develop and implement department standards and practices.
    • Direct the statistical design, conduct, and analysis of clinical trials in all phases.
    • Review protocols and case report forms for soundness of trial design.
    • Review and or author statistical analysis plans for all phases of a trial.
    • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
    • Direct the development, validation and summary of integrated safety and efficacy summaries.
    • Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
    • Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
    • Contribute to the development of Requests-for-Proposals.
    • Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
    • Responsible for all statistical oversight within a therapeutic area.

Please have:

• • MS/MS degree in Statistics/Biostatistics and 10 years’ industry experience or PhD and 7 years.
  • Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to Oncology trials.
  • Developed/reviewed SDTM/ADaM specifications.
  • Excellent knowledge of FDA/EU statistical guidelines.
  • Experience in state-of-the-art data organization and statistical analyses using statistical software such as: R and SAS.
  • Understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs and drug safety.
  • Project management and contract negotiation with outside vendors.