The Director of Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Independently provides strategic statistical input to drug development planning, including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions, and follow up. Contributes to establishing and driving strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Clinical Scientists, Data Management, Clinical Operations, Pharmacovigilance, and Regulatory teams providing overall statistical leadership, direction, and consulting as it relates to the design, analysis, and reporting of clinical trials in support of all Phases of clinical development and regulatory submission programs. Represents Biostatistics in core project team meetings on operational and strategic decision- making related to assigned projects. This individual is also accountable for production of Biostatistics deliverables by providing oversight of the work performed by CROs, managing external (and/or internal) Biostatistics and Statistical Programming resources, or performing the work themselves.
This position reports to the Senior Director, Biometrics. As an individual contributor, the successful candidate will be both a strong hands-on executor as well as strategic manager of internal and external partners.
Essential Duties and Responsibilities:
- Provide statistical and programming input to ensure program objectives are in alignment with Biometrics standards, as well as regulatory and commercial needs
- Collaborate with project management, clinical and regulatory functions
- Coordinate biostatistical and statistical programming activities, including hands-on work
- Serves as primary author on statistical sections of protocols and study reports including publications, and statistical analysis plans
- Responsible for the efficient management of statistical and programming resources
- Contributes to forecasting resources and communicates all changes in the plans or expectations in a timely and effective manner
- Ensure timeliness and quality of deliverables
- Contribute in developing ADaM standards, specifications and datasets
- Manage junior statisticians and guide statistical programming efforts on key statistical analyses
- PhD or MS in statistics or related field and at least 12 years of pharma / biotech industry experience. Rare disease experience is a plus
- Comprehensive knowledge of clinical trials methodology, and statistical software packages. Proficiency in SAS required, and knowledge of other languages (e.g. R) is a plus
- Able to collaborate effectively with internal and external study management teams to meet project timelines
- Must be solution-oriented and educate study team members in appropriate interpretation of designs and results
- Excellent interpersonal, verbal and written communication skills required
- Strong work ethics working as a team member or individually
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
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 requires you to work onsite 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.