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

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

12+ years (Bachelors); 10+ years (Masters); 8+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
Industry experience in the statistical analysis of biomedical data using statistical software
Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation
Demonstrated effective verbal and written communication skills and interpersonal skills
Ability to examine functional issues from a broader organization perspective
Proven ability to determine the functions most critical to company success and to support priorities within functions

Responsibilities

Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support
Serve as Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
Work 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
Direct internal and external teams across multifunctional project or functional areas, lead initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, work with management and Human Resources to satisfy short-term staffing needs, defend statistical aspects with regulatory agencies, develop staff capabilities, and recognize/reward desired performance
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
Lead two or more components of departmental strategic initiatives

Skills

Biostatistics

Statistical Analysis

Clinical Trials

Oncology

Regulatory Interactions

HTA

Drug Development

SAS

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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