Sr Manager, 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

Pharmaceuticals, BiotechnologyIndustries

Requirements

Advanced degree in biostatistics, statistics, or related field (implied by senior role and responsibilities)
Extensive experience in biostatistics, particularly in clinical development, trial design, and NDA submissions
Proven leadership in managing biostatistical analysis, teams, and cross-functional collaborations
Expertise in statistical consultation, sample size calculation, authoring statistical analysis plans, and regulatory filings
Ability to handle projects of increasing complexity, including non-molecule based activities like tools, programming, and centralized analyses
Strong skills in data gathering, organization, analysis, safety reporting, and biomarker analysis

Responsibilities

Acts as biostatistics lead on clinical studies or other non-molecule projects
Leads statistical analysis, document review, and data inclusion for NDA submissions of assigned studies by collaborating with Biostatistics team members and cross-functional partners
Provides statistical consultation on trial design, study endpoints, and authors statistical analysis plans
Oversees and contributes to completion of all technical and operational statistical activities for a group of clinical trials
Directs internal and external teams in the definition, execution, and completion of statistical activities for one or more molecules or marketed products
Participates in cross-functional clinical development planning, protocol design, and review discussions for one or more molecules or marketed products
Advises internal and external partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation/presentation of statistical results
Leads the gathering, organization, and analysis of different data sources to enable delivery of special projects, statistical analysis plans, and clinical study endpoints for assigned products
Reviews and analyzes safety reporting and biomarker analysis
Contributes to short- and long-range Biostatistics strategies, plans, and infrastructure development across multiple areas and teams

Skills

Key technologies and capabilities for this role

BiostatisticsStatistical AnalysisClinical Trial DesignSample Size CalculationStatistical Analysis PlansRegulatory FilingsNDA SubmissionsStatistical ProgrammingCentralized Analyses

Questions & Answers

Common questions about this position

What are the main responsibilities of the Sr Manager, Biostatistics role?

The role involves leading biostatistical analysis and reporting, document review and data inclusion for NDA submissions, providing statistical consultation on clinical development plans, trial design, and endpoints, authoring statistical analysis plans, and contributing to biostatistics strategies and infrastructure development.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders playing a key role in evolving the culture to make every employee feel included, developed, and empowered.

What makes a strong candidate for this Sr Manager, Biostatistics position?

Strong candidates will have experience acting as a biostatistics lead on clinical studies, leading statistical analysis for NDA submissions, providing consultation on trial design and endpoints, and authoring statistical analysis plans, particularly for projects of increasing complexity.

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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