Associate Director, Biostatistics at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Advanced knowledge of biostatistical analysis and reporting for clinical studies and NDA submissions
Experience providing statistical consultation on clinical development plans, trial design, study endpoints, and sample size calculations
Proficiency in authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings
Ability to lead projects or activities, including non-molecule based ones like biostatistics tools, programming, centralized analyses, and reporting
Capability to contribute to short- and long-range Biostatistics strategies, plans, and infrastructure development across teams
Expertise in using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data
Skills in planning and documenting computer data file structures, programming, managing, and maintaining complex statistical databases, and performing/supervising data entry
Experience developing enhancements to statistical software

Responsibilities

Act as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions, collaborating with biostatistics team members and cross-functional partners
Provide statistical consultation on trial design and study endpoints, author statistical analysis plans, and lead projects of increasing complexity or size
Oversee and contribute to the completion of technical and operational statistical activities for groups of clinical trials, and direct teams in the definition, execution, and completion of statistical activities for molecules or marketed products
Participate in cross-functional clinical development planning and protocol design discussions to provide biostatistical input
Advise partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results
Lead the gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products
Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring
With increasing independence, lead biostatistical analysis and reporting while collaborating with cross-functional partners to meet clinical development project deliverables and timelines

Skills

Biostatistics

Statistical Analysis

Clinical Trial Design

Sample Size Calculation

Statistical Analysis Plans

Statistical Programming

Regulatory Filings

NDA Submissions

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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