Associate Director, Biostatistics- Virology

Gilead Sciences Inc.; Foster City (CA); Hybrid; USD 178,000 - 253,000; Full time

Job summary

Gilead Sciences Inc. in the San Francisco Bay Area seeks an Associate Director, Biostatistics to provide strategic and operational statistical input for clinical development programs in Virology.

You will represent Biostatistics on study management and development teams, collaborating across Clinical Development, Patient Safety, Regulatory Affairs and more to ensure high-quality planning, analysis, interpretation, and reporting. The role is on-site with hybrid flexibility.

Qualifications

• Lead statistician for Phase 1-3 clinical trials with overall statistical strategy.
• Statistical input into study design, endpoints, analysis methods, SAPs, and CSR reviews.
• Adheres to regulatory requirements and company SOPs.

Responsibilities

• Represent Biostatistics on study management teams and development teams.
• Provide statistical input into trial design, endpoints, analysis methods, and SAPs.
• Lead or contribute to regulatory documentation and scientific publications.

Skills

Biostatistics expertise

Clinical trial statistics

Education

BS/BA with 10+ years

MS/MA or MBA with 8+ years

PhD with 5+ years

Tools

R

SAS

Job description

At Gilead, we are creating a healthier world for all people. For more than 35 years, we have 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 are 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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Associate Director, Biostatistics, you will provide strategic and operational statistical input for clinical development programs within the Virology Therapeutic Area.

You will represent Biostatistics at study management team and development team for multiple studies, collaborate closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, Clinical Data Management to ensure high-quality statistical planning, analysis, interpretation, and reporting.

This may include, but is not limited to, providing statistical strategic input into study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs and CSR review, and providing biostatistical input into scientific publications and presentations, and regulatory requests. In addition to clinical trials, you may lead or contribute to other activities that are non-molecule based, such as department strategic initiatives or working groups.

This position is an on site/ hybrid role requiring the candidate to be on site 3 days a week.

Key Responsibilities

• Serve as lead statistician for Phase 1-3 clinical trials with responsibility for overall statistical strategy and delivery
• Represent Biostatistics on study management teams and development teams, providing strategic statistical input, and collaborate closely with other Biostatistics team members and cross-functional team.
• Provides statistical consultation on trial design, endpoints, analysis methods, and author statistical analysis plans
• Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret historical and external data to derive useful information for clinical development.
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Requirements

• 10+ Years of relevant experience with BS/BA OR
• 8+ Years of relevant experience with MS/MA or MBA OR
• 5+ years of relevant experience with PhD

Preferred

PhD is strongly preferred for this position

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.

Salary range for this position is:
Bay Area: $195,670.00 - $253,220.00.
Other US Locations: $177,905.00 - $230,230.00.

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.

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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.