Associate Director, Biostatistics at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Increasing independence in leading biostatistical analysis, reporting, document review, and data inclusion for NDA submissions
Ability to collaborate with cross-functional partners to meet clinical development project deliverables and timelines
Expertise in providing statistical consultation on clinical development plans, clinical trial design, and study endpoints
Proficiency in calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings
Capability to lead non-molecule based projects, such as biostatistics tools, programming, centralized analyses, and reporting
Contribution to short- and long-range Biostatistics strategies, plans, and infrastructure development across teams
Use of 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 in developing enhancements to statistical software

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 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

Skills

Key technologies and capabilities for this role

BiostatisticsStatistical AnalysisClinical Trial DesignSample Size CalculationStatistical Analysis PlansRegulatory FilingsNDA SubmissionsStatistical ProgrammingClinical Development

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What are the key responsibilities and skills needed for the Associate Director, Biostatistics role?

The role requires leading biostatistics activities on clinical studies, providing statistical consultation on trial design and endpoints, authoring statistical analysis plans, and collaborating with cross-functional partners on NDA submissions and regulatory filings.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered. Every team member plays a critical role in scientific innovations.

What makes a strong candidate for this biostatistics leadership role?

Strong candidates will have experience leading biostatistics for clinical studies with increasing independence, expertise in statistical consultation for trial design, sample size calculation, and authoring analysis plans, plus the ability to collaborate cross-functionally and contribute to strategic infrastructure development.

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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