Senior Director, Biostatistics

Location
San Francisco, CA, United States
Posted
Nov 15, 2018
Ref
381
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
SENIOR DIRECTOR, BIOSTATISTICS

Position Summary:

The Senior Director, Biostatistics is accountable for all Global Blood Therapeutics (GBT) Biostatistics deliverables, including study design, data analysis, interpretation and reporting of results, publication, and regulatory submission, in collaboration with partner functions in Development and Medical Affairs. Provides statistical expertise and general program input into GBT drug development plans and global regulatory interactions. Collaborates with counterparts in Clinical Data Management and Statistical and Clinical Programming in providing Biometrics leadership and support of all phases of clinical development activities including medical communication and regulatory submissions. Attends health authority meetings as a member of the sponsor team. Represents GBT Biometrics on industry, academia and health authority collaboration projects to enhance disease education and/or regulatory innovation in therapeutics development for sickle cell disease as appropriate. Leads Biostatistics organizational strategy and manages internal and CRO resources as needed. Leads or contributes to Biostatistics SOP development and maintenance, and other department initiatives.

Essential Duties and Responsibilities:
  • Lead GBT Biostatistics in providing statistical expertise and support to Development and Medical Affair clinical programs, publications, and regulatory submissions
  • Represent Biostatistics on clinical development team and/or study teams as needed; assure statistical integrity, adequacy and accuracy of statistical analysis and result interpretation
  • Provide input in the selection of CROs, manage CRO activities for clinical studies in collaboration with internal partner functions to ensure timely delivery of project commitments
  • Cultivate collaborative working relationships with functional partners, including external contract or advisory organizations, and thought leaders
  • Lead or contribute to the development of complex, technical solutions for projects or business needs
  • Lead or contribute to the development and maintenance of SOPs and WIs for Biostatistics
  • Lead or contribute to industry/academia/health authority collaborations in SCD disease education, or regulatory innovation on behalf of GBT Biometrics
  • Lead Biostatistics resource planning and manage direct reports as needed

Qualifications:

The successful candidate will be a strategic leader and a hands-on contributor with a proven track record of supporting complex drug development programs.
  • PhD in Statistics or Biostatistics with at least 12 years of pharma / biotech industry experience, or MS in Statistics or Biostatistics with at least 15 years of industry experience, and 5+ years of team leadership or management experience
  • Expert knowledge in the principles and techniques of clinical study design, data analysis and interpretation, and data-driven decision making
  • Comprehensive understanding of regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission required
  • Proficiency in SAS required, and knowledge of other languages (e.g. R) is a plus
  • Excellent team leadership, verbal and written communication skills
  • Strong critical thinking, problem solving and project management skills
  • Team-builder who models entrepreneur spirit and fosters cross-functional collaborations

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.