Associate Director, Biostatistics jobs in United States
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Gilead Sciences · 1 week ago

Associate Director, Biostatistics

Gilead Sciences is committed to creating a healthier world for all people and has been at the forefront of tackling major diseases. The Associate Director of Biostatistics will lead biostatistical analysis and reporting for clinical studies, collaborating with cross-functional partners to ensure project deliverables are met.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Acting as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions by collaborating with other biostatistics team members and cross-functional partners
Providing statistical consultation on trial design and study endpoints, authoring statistical analysis plans, and leading projects of increasing complexity or size
Overseeing and contributing to the completion of technical and operational statistical activities for groups of clinical trials, and directing teams in the definition, execution, and completion of statistical activities for molecules or marketed products
Participating in cross-functional clinical development planning and protocol design discussions to provide biostatistical input
Advising partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results
Leading the gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products
Reviewing and analyzing safety reporting, biomarker analyses, and other aspects of clinical trial monitoring
Using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development
Planning and documenting computer data file structures, development: Message, programming, managing, and maintaining complex statistical databases, and performing or supervising data entry
Developing enhancements to statistical software and maintaining knowledge of current and emerging trends in statistical analysis methodologies and tools
Providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation
Participating in or leading special projects that benefit multiple team members, such as new methodologies, processes, technology, and tools, and contributing to the development and implementation of SOPs and related documentation
Providing matrix management to supported projects and independently defining required resources for assigned work
Adhering to regulatory requirements, statistical analysis principles, industry standards, and company SOPs

Qualification

PhD in BiostatisticsSAS software proficiencyBiomedical statistical analysisStatistical analysis plansDrug development knowledgeProject management experienceCommunication skillsOrganizational skillsTeam leadership

Required

PhD with 6+ years of biostatistics experience is preferred
MS in biostatistics or related discipline with 8+ years of relevant experience in statistical analysis of biomedical data using SAS software
Minimum of 2 years of cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry, including multiple years of experience managing project teams
Significant biomedical statistical analysis experience and proficiency with relevant software and tools
Experience developing software and tools to support statistical analysis of biomedical or related data
Proven effectiveness in managing projects and teams
Advanced knowledge of biomedical statistical analysis, biostatistics best practices, and tools, with demonstrated ability to apply these to improve results
Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes
Understanding of drug development phases, clinical trials, FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures
Strong communication and organizational skills, and ability to travel when needed

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