Gilead is seeking an Executive Director of Biostatistics for Inflammation to lead the Biostatistics function within the Inflammation Therapeutic Area, overseeing all biostatistics workstreams for clinical trials, asset evaluations, and regulatory submissions. The role aims to ensure the scientific integrity and rigorous statistical approaches in clinical trials, driving Gilead's mission to create a healthier world.
Requirements
- Inflammation drug development experience is required, including the design and conduct of clinical studies from early through late stage development and regulatory interactions.
- In depth knowledge of the drug development process.
- In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance.
- Ability to integrate planning efforts across departments to ensure organizational effectiveness.
- Ability to advise and influence senior leadership/functional leads on biostatistics strategies as well as functional issues that have a business impact.
- Ability to use competitive intelligence to influence clinical development strategies.
- PhD degree in Biostatistics or equivalent and minimum 15 years of industry experience is preferred.
Responsibilities
- Provides statistical oversight of all biostatisticians in the TA and all biostatistics-related work conducted by internal biostatisticians and external consultants for the TA.
- Provides strategic inputs and statistical expertise for clinical development programs.
- Oversees and contributes to the completion of all technical and operational statistical activities in the TA through management of internal and external resources.
- Ensures adherence to SOPs, BEDs, and all departmental standards and processes regarding the conduct of clinical trials, statistical methodology, data analysis and interpretation.
- Champions the development and training of decision-enabled statistical tools.
- Explores opportunities for more efficient and innovative statistical approaches.
- Responsible for ensuring scientific integrity of the statistical methodology applied to clinical trials.
Other
- Proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development.
- Excellent verbal and written communication skills.
- Excellent negotiation and interpersonal skills
- Proven ability to supervise team leads who supervise personnel.
- Ability to delegate, coach, and provide feedback and career development opportunities to team-members.
