Director, Head Of Statistical Programming

Portola Pharmaceuticals South San Francisco , CA 94080

Posted 3 months ago

Director, Head of Statistical Programming

Position Summary

The Director, Head of Statistical Programming, has overall responsibility for the statistical programming function at Portola. The successful candidate will work closely with Biostatistics, Data Management and other functional leaders to ensure quality of CDISC datasets and statistical analysis, set up efficient tools and processes, and collaborate with IT to secure computing and analytical environment. This position will report to Head of Biometrics.

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Responsibilities

  • Lead the programming team to plan and execute programming deliverables for multiple projects simultaneously

  • Manage, recruit and develop the programming team members

  • Manage vendors regarding programming issues and activities, including performing vendor qualifications and providing oversight of vendors to ensure timely and quality delivery of datasets and TFL

  • Create or review programming plans for individual studies and overall projects, including specifications for CDISC datasets and TFLs

  • Develop and maintain programming infrastructure to support CSR, ad hoc analysis, publications, DSUR, etc

  • Implement programming SOPs and work instructions, including programming validation and documentation

  • Create tools and improve processes to improve programming efficiency and quality

  • Prepare and manage budget for programming team

Qualifications

  • At least Bachelor degree in Computer Science, Mathematics, Statistics, Pharmaceutical Sciences, Life Sciences and/or related areas

  • Minimum of 15 years of relevant experience in pharmaceutical or biotechnology industry, with at least 6 years of demonstrated success in a management role; experience with small biotech companies and high paced work environment is a plus

  • Excellent knowledge of SAS programming and associated areas and their application to the pharmaceutical industry

  • Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation

  • Experience in multiple FDA and EMEA filings

  • Excellent oral and written communication skills

  • Good organizational and problem-solving skills, as well as the ability of evaluating resource needs periodically

  • 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.


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Director, Head Of Statistical Programming

Portola Pharmaceuticals