Job Description
AtGileadour 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 worlds 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 6 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 authors 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 -knowingthe 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 employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, 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: $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.
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