Associate Director - Biostatistics, Virology

February 27

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $195.7k - $253.2k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that has been tackling public health challenges for over 35 years. The company is known for revolutionizing the treatment and prevention of HIV and providing a cure for hepatitis C. With a focus on virology, oncology, and inflammation, Gilead aims to deliver transformative therapies and advance health equity globally. They emphasize scientific innovation to develop next-generation cancer therapies and inclusive clinical trials to address diseases such as HIV. Gilead is also involved in various strategic initiatives and corporate giving programs to support global health and access.

10,000+ employees

Founded 1987

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support. • Statistical lead for specific Virology molecule/indication in Health Authority interactions and maintain accountability thread to TA head. • Work 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. • Direct internal and external teams across multifunctional project or functional areas, lead initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking. • Work with management and Human Resources to satisfy short-term staffing needs, defend statistical aspects with regulatory agencies, develop staff capabilities, and recognize/reward desired performance. • 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. • Lead two or more components of departmental strategic initiatives.

🎯 Requirements

• 10+ years (Bachelor's); 8+ years (Master's); 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 teams • 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

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical, dental, vision, and life insurance plans