Associate Director, Biostatistics

Gilead Sciences, Inc.; Foster City (CA); Remote; USD 195,000 - 254,000; Full time

Job summary

An established industry player is seeking an Associate Director of Biostatistics to lead statistical analysis for Virology drug development. This role involves collaborating with various teams to ensure the design and reporting of clinical data meet regulatory and business objectives. The ideal candidate will have extensive experience in statistical analysis within the pharmaceutical sector, showcasing strong leadership and communication skills. Join a dynamic team dedicated to making a significant impact on global health challenges and be a part of exciting drug discovery initiatives. This position offers a competitive salary and a comprehensive benefits package, making it an excellent opportunity for passionate professionals.

Benefits

Discretionary Annual Bonus

Stock-Based Long-Term Incentives

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Qualifications

• 10+ years of statistical analysis experience in the pharmaceutical industry.
• Proven ability to lead teams and manage drug development projects.

Responsibilities

• Provide statistical leadership for Virology clinical trials.
• Collaborate with teams to meet project deliverables and timelines.

Skills

Statistical Analysis

Communication Skills

Team Leadership

Drug Development

Regulatory Interactions

Education

Bachelor's Degree

Master's Degree

PhD

Tools

Statistical Software

Job description

Associate Director, Biostatistics

United States – Remote, United States - California - Foster City Clinical Development & Clinical Operations Regular

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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. 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.
• Demonstrated effective verbal and written communication skills and interpersonal skills are required.
• Examines functional issues from a broader organization perspective.
• Proven ability to determine the functions most critical to company success and to support priorities within functional area.
• Anticipates obstacles and difficulties of clients and acts to meet goals.
• Proven ability to pull together and lead highly effective teams and create a clear sense of direction.
• Proven ability to design and use all available vehicles for effective scientific communication within and outside the company.

The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.