Director, Biostatistics jobs in United States
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Gilead Sciences · 2 days ago

Director, Biostatistics

Gilead Sciences is dedicated to creating a healthier world by developing therapies for serious diseases. The Director of Biostatistics will lead statistical efforts in Virology drug development, ensuring high-quality analysis and regulatory compliance while collaborating with various teams to meet project goals.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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 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
Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance
Is expected to 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
Leads two or more components of departmental strategic initiatives

Qualification

Statistical analysisClinical trial designRegulatory submissionsSASREffective communicationCollaboration skillsInterpersonal skillsProblem-solvingTeam leadership

Required

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

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 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

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Company

Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

H1B Sponsorship

Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)

Funding

Current Stage
Public Company
Total Funding
$4.41B
Key Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B

Leadership Team

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Keeley Wettan
Senior Vice President, Legal
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Patrick Loerch
Senior Vice President, Clinical Data Science
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Company data provided by crunchbase