Gilead Sciences
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Director, Biostatistics
role at
Gilead Sciences .
Job Description At Gilead, we’re creating a healthier world for all people. We tackle diseases such as HIV, viral hepatitis, COVID‑19 and cancer. 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. We’re looking for passionate, ambitious people ready to make a direct impact.
Position Overview The Biostatistics function works collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data, efficiently achieving regulatory, scientific and business objectives. The Director will be primarily responsible for the business, operational, and compliance aspects of Oncology drug discovery, development, and marketed products. He/she will support oncology late‑stage development, collaborating on development plans, regulatory interactions and HTA/commercial evaluation of a Gilead Oncology compound in one or more indications.
Key Responsibilities
Provide statistical leadership to late‑stage oncology clinical trials: developing trial design options and providing high‑quality decision support.
Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head.
Work collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical staff to meet project deliverables and timelines for statistical data analysis and reporting.
Direct internal and external teams across multifunctional projects, lead initiatives to gather, organize, and analyze data from different sources, work with management and Human Resources to satisfy short‑term staffing needs, defend statistical aspects with regulatory agencies, develop staff capabilities, and recognize and 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.
Education & Experience
12+ years (Bachelor’s); 10+ years (Master’s); 8+ years (PhD) of statistical analysis experience in the pharmaceutical/biotechnology industry or at a CRO.
Experience in statistical analysis of biomedical data using statistical software; extensive hands‑on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation.
Demonstrated effective verbal and written communication and interpersonal skills.
Ability to examine functional issues from a broader organizational perspective, determine critical functions, and support priorities within the functional area.
Anticipates obstacles and addresses them to meet goals.
Ability to pull together and lead highly effective teams and create a clear sense of direction.
Ability to design and use all available channels for effective scientific communication within and outside the company.
Salary range for this position is $226,185.00 - $292,710.00, based on experience, qualifications and location.
Eligibility for discretionary annual bonus, stock‑based long‑term incentives (subject to role variation), paid time off and a benefits package including company‑sponsored medical, dental, vision and life insurance plans.
Benefits
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 and fosters an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status or other non‑job related characteristics. Reasonable accommodation can be requested at ApplicantAccommodations@gilead.com.
Gilead Sciences does not discriminate against employees or applicants for discussing pay. Employees with access to compensation information must keep it confidential unless required by law.
Gilead provides a harassment‑free work environment, respects individual differences and celebrates diversity.
#J-18808-Ljbffr
Director, Biostatistics
role at
Gilead Sciences .
Job Description At Gilead, we’re creating a healthier world for all people. We tackle diseases such as HIV, viral hepatitis, COVID‑19 and cancer. 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. We’re looking for passionate, ambitious people ready to make a direct impact.
Position Overview The Biostatistics function works collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data, efficiently achieving regulatory, scientific and business objectives. The Director will be primarily responsible for the business, operational, and compliance aspects of Oncology drug discovery, development, and marketed products. He/she will support oncology late‑stage development, collaborating on development plans, regulatory interactions and HTA/commercial evaluation of a Gilead Oncology compound in one or more indications.
Key Responsibilities
Provide statistical leadership to late‑stage oncology clinical trials: developing trial design options and providing high‑quality decision support.
Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head.
Work collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical staff to meet project deliverables and timelines for statistical data analysis and reporting.
Direct internal and external teams across multifunctional projects, lead initiatives to gather, organize, and analyze data from different sources, work with management and Human Resources to satisfy short‑term staffing needs, defend statistical aspects with regulatory agencies, develop staff capabilities, and recognize and 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.
Education & Experience
12+ years (Bachelor’s); 10+ years (Master’s); 8+ years (PhD) of statistical analysis experience in the pharmaceutical/biotechnology industry or at a CRO.
Experience in statistical analysis of biomedical data using statistical software; extensive hands‑on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation.
Demonstrated effective verbal and written communication and interpersonal skills.
Ability to examine functional issues from a broader organizational perspective, determine critical functions, and support priorities within the functional area.
Anticipates obstacles and addresses them to meet goals.
Ability to pull together and lead highly effective teams and create a clear sense of direction.
Ability to design and use all available channels for effective scientific communication within and outside the company.
Salary range for this position is $226,185.00 - $292,710.00, based on experience, qualifications and location.
Eligibility for discretionary annual bonus, stock‑based long‑term incentives (subject to role variation), paid time off and a benefits package including company‑sponsored medical, dental, vision and life insurance plans.
Benefits
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 and fosters an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status or other non‑job related characteristics. Reasonable accommodation can be requested at ApplicantAccommodations@gilead.com.
Gilead Sciences does not discriminate against employees or applicants for discussing pay. Employees with access to compensation information must keep it confidential unless required by law.
Gilead provides a harassment‑free work environment, respects individual differences and celebrates diversity.
#J-18808-Ljbffr