Senior Director, Biostatistics (Remote)

Location
Working from Home
Posted
Jul 01, 2022
Ref
4538690004
Required Education
Masters Degree/MBA
Position Type
Full time

SENIOR DIRECTOR, BIOSTATISTICS (Remote)

Position Summary:

The Senior Director, Biostatistics is accountable for all or parts of Global Blood Therapeutics, Inc. (GBT) Biostatistics deliverables, including study design, data analysis, data mining, epidemiology-related analyses, use of clinical trial data to inform reimbursement strategy and HTA required analyses, real world evidence, quality of life data, and interpretation, reporting, and publication of results in collaboration with partners in Medical Affairs.

Essential Duties and Responsibilities:

  • Provides statistical expertise and general program input into GBT Medical Affairs programs and strategy
  • Collaborates with counterparts in Clinical Biostatistics, Clinical Data Management, Statistical and Clinical Programming in providing Biometrics leadership and provides support for a broad range of activities in the Medical Affairs function
  • Represents GBT Biometrics in Medical Affairs activities 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 Medical Affair Biostatistics organizational strategy and manages internal and CRO resources as needed
  • Leads and contributes to Biostatistics SOP development and maintenance, and other department initiatives as directed by the head of department
  • Lead all statistical activities in providing expertise and support to Medical Affair research programs, publications, data mining, and other evidence generating activities as required
  • Represent Biostatistics on Medical Affairs team and/or study teams as needed; assure statistical integrity, adequacy and accuracy of statistical analysis and result interpretation
  • Oversees development of statistical sections of protocol, SAP, and reports as needed
  • Manages the implementation of statistical analysis plans, data analysis strategies, and interpreting the resulting findings, with a keen understanding of the impact of statistical decisions to the end-user (e.g., ex-US HTA bodies, clinicians)
  • Provide input in the selection of CROs, manage CRO activities for analyses in collaboration with internal partner functions to ensure timely delivery of project commitments with quality
  • 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 Work Instructions for Biostatistics and provide input for other Biometrics SOP within Programming and Data Management
  • 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 
  • Contribute and engage with strategic decision making within Biometrics as needed
  • Work with Biometrics counterparts on key statistical analyses, and Contribute to developing ADaM standards, specifications and datasets as needed
  • Contribute in setting standards within Biometrics
  • Adheres to and enforces the latest regulatory guidelines as applicable

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, Biostatistics or Epidemiology with emphasis in statistics with at least 12+ years of pharma / biotech industry experience, or MS in Statistics, Biostatistics or Epidemiology with emphasis in statistics with at least 18 years of industry experience, and 5+ years of team leadership or management experience
  • Expert knowledge in the principles and techniques of post-marketing study design, data analysis and interpretation, and data-driven decision making. Familiarity with rare disease therapeutic areas is a plus
  • Experience designing and analyzing data from disease and/or product registry studies
  • Deep understanding of Medical Affairs statistical activities (e.g. RWE data generation, reimbursement filing, data mining, use of external data including historical control data.
  • Experience generating data analysis plans and strategies for a payer/access audience preferred
  • SAS proficient and ability to write code and provide guidance to SAS programmers for various activities within Medical Affairs. Knowledge of other languages (e.g. R) is a plus
  • Familiarity with regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission required
  • Familiarity with CDISC standards
  • 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.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.