Director, Statistical Programming

San Francisco, CA
Nov 02, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

The Director, Statistical Programming oversees all clinical study programming activities, including the production of study report deliverables performed by statistical CROs, for assigned Clinical Development programs. Manages internal and external programming resources. Coordinates data sharing activities with partner organizations. Represents Statistical Programming on clinical study teams. Collaborates with project counterparts in Clinical Data Management and Biostatistics in providing Biometrics leadership and expertise in support of all phases of clinical development activities and regulatory submissions. Develops and maintains good communications and working relationships with internal/external functions. Contributes to GBT Biometrics strategy and implementation for resourcing and standard process.

Essential Duties and Responsibilities:
  • Ensure timely and accurate delivery of tables, listings, and graphs for clinical study reports, regulatory submissions, study publications
  • Ensure company business needs and partner organizations are satisfied within agreed-upon timelines with respect to statistical programming activities for clinical studies
  • Create and/or review project documentations before start of programming for accuracy and completeness to meet project goals
  • Lead the development of complex, technical solutions for projects or business needs
  • Contribute to the development and maintenance of SOPs and WIs for Statistical Programming
  • Provide input in the selection of CROs, manage CRO programming activities for clinical studies
  • Lead Statistical Programming resource planning for assigned projects; manage direct reports as needed

  • BA, BS or advanced degree in statistics, computer science, mathematics, or biological sciences
  • At least 10 years of pharma/biotech industry experience in statistical programming supporting clinical study data analysis; regulatory submission experience preferred
  • Expert proficiency in SAS required; knowledge of multiple statistical software packages a plus
  • Thorough understanding of metadata and CDISC standards
  • Excellent interpersonal, verbal and written communication skills
  • Capable of high complexity problem solving and issue resolution
  • Strong team leadership and project management skills

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

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