Director, Biostatistics, Oncology and Non-Cardiovascular Programs

Biometrics South San Francisco, California


Description

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Director, Biostatistics

(Oncology and Non-Cardiovascular Programs)

 

 

 

Position Summary

The Director, Biostatistics will act as the strategic and technical leader for the oncology and non-cardiovascular development programs.  The Director will supervise his/her biostatistical personnel to provide all biostatistical deliverables and play a critical role in development programs and regulatory submissions globally.  This position will report to Head of Biometrics.

 

Responsibilities

  • Serve as lead statistician on project teams, providing strategic and operational expertise for all stages of oncology and non-cardiovascular clinical development programs and support of other functions
  • Manage, recruit and develop junior biostatisticians
  • Collaborate closely with Biometrics members and other functional leaders
  • Write or review protocols, SAP, CSR and other related documents to ensure scientific integrity of the applied statistical methodology
  • Direct junior biostatisticians and vendors to perform all statistical related tasks
  • Ensure quality review of IVRS instructions, case report forms and other study documents
  • Interact with Regulatory agencies at face-to-face meetings or through correspondence
  • Plan and manage all biostatistical activities
  • Lead statistical research in clinical development
  • Performs other duties as assigned

 

Qualifications

  • Master’s Degree in Statistics, Biostatistics or related fields with 15+ years or PhD with 10+ years of pharmaceutical experience
  • At least 5 years of demonstrated success in a management role
  • Proven knowledge and expertise in statistics and its application to clinical trials
  • Solid knowledge and experience in drug development process
  • Experience in study designs, data collection, and statistical analysis methods pertaining to oncology studies
  • Prior experience with regulatory submissions required
  • Solid Knowledge of statistical software packages, such as SAS® and R
  • Good understanding of CDISC models and standards
  • Experience interacting with the FDA and other regulatory authorities
  • In-depth knowledge of regulatory regulations and ICH guidelines
  • Experience in FDA and EMEA filings
  • Strategic thinker
  • Able to thrive in a small group setting, possesses high energy hands-on attitude
  • Strong leadership, cross-functional collaboration, communication and presentation skills
  • Amount of travel: Up to 10%

 

 

Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.