Associate Director, Biostatistics - Virology

Job Description

Job Description

Associate Director, Biostatistics

Position Overview:

Are you passionate about leveraging your biostatistical expertise to make a meaningful difference for patients? Are you interested in an exciting opportunity to immediately gain more direct experience with regulatory submissions? Join our Biostatistics team and take on a pivotal role in shaping our on-going regulatory submissions. If you have a solid background in clinical trial design and analysis and are eager to tackle challenges that drive scientific and regulatory advancements, we want you to be part of our team!

Biostatisticians at Gilead work collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives. The Associate Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead. He/she will support Virology drug development, working collaboratively for the development plans, regulatory interactions, and commercial evaluation of a Gilead Virology compound in one or more indications.

Key Responsibilities:

• Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support.
• Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
• Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
• Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance
• Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources
• Leads two or more components of departmental strategic initiatives

Education & Experience

• 10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
• Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred)
• Extensive hands-on experience in drug development including design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation
• Effective verbal and written communication skills with the ability to convey complex concepts in clear, concise, and accessible language
• Strong collaboration and interpersonal skills with demonstrated success in fostering effective relationships and working seamlessly within diverse cross-functional team
• Adept at analyzing challenges from a holistic, cross-functional viewpoint to align with broader organizational or project goals
• Anticipates obstacles and understands stakeholder needs to proactively develop and implement practical and effective solutions
• Demonstrated ability to assemble and lead high-performing teams, providing clear direction and fostering a shared vision for success