Senior Director​/Director of Biostatistics

Senior Director/Director of Biostatistics

Reporting to: VP, Biostatistics.

Required

Location:

Palo Alto, CA – Three days a week onsite.

• Represent Statistics in multiple projects of cross‑functional process and standards development/improvements, and infrastructure initiatives and evaluations.
• Represent Statistics in all assigned cross‑functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects including but not limited to providing quality deliverables.
• Provide statistical guidance into clinical development plans, work on clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.
• Review protocol, conduct/QC sample size calculations, develop statistical analysis plan, and Data Monitoring Committee (DMC) charter, review study documents for clinical trials in oncology.
• Partner with cross‑functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results, and assists in the development and review of regulatory submission documents.
• Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses.
• Support and participate in the development of departmental strategies, and cross‑functional initiatives on standards/infrastructure/processes.
• Support and assist Biometrics Lead in both strategy developments and operations.
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met.

• Master or PhD in Statistics, Biostatistics, Mathematics or closely related field.
• Minimum 10 years (12 years with master’s degree) of experience in oncology drug development in pharmaceutical industry R&D.
• For SD position: at least 3-5 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team.
• Experience in planning, conducting and analyses of oncology trials from phase I-IV.
• Experience in answering health authority questions (FDA, EMA, and/or PMDA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages.
• Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian a plus), regulatory guidelines (ICH, FDA, EMA, PMDA).
• Excellent knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery).
• Outstanding analytical skills: ability to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross‑functional colleagues.
• Strong drive for achieving high quality work results in a timely manner, while always safeguarding ethical standards in work and behaviors.