Gilead Sciences, Inc.
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.
Join our Biostatistics team and take on a pivotal role in shaping our ongoing regulatory submissions. If you have a solid background in clinical trial design and analysis and are eager to tackle challenges that drive scientific and regulatory advancements, we want you to be part of our team.
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 Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead.
This site‑based role is located at our global headquarters in Foster City, CA.
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.
Collaborate 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 data, 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.
Basic Qualifications
PhD with 8+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO).
Master’s Degree with 10+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO).
Bachelor’s Degree with 12+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO).
Preferred Qualifications
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.
The salary range for this position is:
$226,185.00 - $292,710.00 . 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.
Equal Employment Opportunity 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 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 prohibited grounds specified in applicable federal, state and local laws. Applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead Sciences will not discriminate against employees or applicants who have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Appropriate safeguards apply to disclosure of compensation information.
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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.
Join our Biostatistics team and take on a pivotal role in shaping our ongoing regulatory submissions. If you have a solid background in clinical trial design and analysis and are eager to tackle challenges that drive scientific and regulatory advancements, we want you to be part of our team.
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 Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead.
This site‑based role is located at our global headquarters in Foster City, CA.
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.
Collaborate 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 data, 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.
Basic Qualifications
PhD with 8+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO).
Master’s Degree with 10+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO).
Bachelor’s Degree with 12+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO).
Preferred Qualifications
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.
The salary range for this position is:
$226,185.00 - $292,710.00 . 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.
Equal Employment Opportunity 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 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 prohibited grounds specified in applicable federal, state and local laws. Applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead Sciences will not discriminate against employees or applicants who have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Appropriate safeguards apply to disclosure of compensation information.
#J-18808-Ljbffr