Director, Biostatistics - Virology - Foster City, CA or Parsippany, NJ (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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

 

The Director, Biostatistics 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.

As a Director of Biostatistics at Gilead, you will...

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 Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.

• Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives.

• Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company.

• Negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles.

• Expected to oversee and contribute to the completion of all technical and operational statistical activities for multiple development programs for a compound or equivalent through management of internal and external resources.

• Provides overall leadership for a departmental strategic initiative with experience directly supervising personnel.

Basic Qualifications:

PhD with 8+ years of industry experience

OR

Masters degree with 10+ years of industry experience

OR

Bachelors degree with 12+ years of industry experience

Preferred Qualifications:

• Extensive hands-on experience in drug development including trial design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation

• Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred)

• 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

• Proactive and creative innovator who applies strategic thinking and statistical expertise to develop practical solutions, improve trial design and execution, and support program- and portfolio- level data-driven decision making

People Leader Accountabilities :  

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.  

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them   on   current performance and future potential. They ensure employees are receiving   the feedback   and insight needed to grow, develop and realize their purpose.  

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.  

The salary range for this position is:

Bay Area: $226,185.00 - $292,710.00.

 

Other US Locations: $205,615.00 - $266,090.00.

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:

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

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact <