Senior Manager, Biostatistics-Oncology at Gilead Sciences

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceutical, OncologyIndustries

Requirements

Ability to lead biostatistical analysis and reporting, document review, and data inclusion for NDA submissions with guidance
Experience providing statistical consultation on clinical development plans, clinical trial design, and clinical 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 projects or activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses, and reporting
Experience acting as biostatistics lead on clinical studies or other non-molecule projects with guidance
Knowledge of overseeing and contributing to technical and operational statistical activities for groups of clinical trials
Ability to direct internal and external teams in statistical activities for molecules or marketed products
Participation in cross-functional clinical development planning, protocol design, and review discussions
Expertise in advising on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation/presentation of statistical results
Proficiency using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data

Responsibilities

With guidance, act as biostatistics lead on clinical studies or other non-molecule projects
Where applicable and with guidance, lead statistical analysis, document review, and data inclusion for NDA submissions of assigned studies by collaborating with Biostatistics team members and cross-functional partners
Provide statistical consultation on trial design and study endpoints and author statistical analysis plans for studies or projects of increasing complexity or size
Where applicable, oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials
Direct internal and external teams in the definition, execution, and completion of statistical activities for one or more molecules or marketed products of increasing complexity
Where applicable, participate in cross-functional clinical development planning for one or more molecules or marketed products to provide biostatistical perspective and input
Where applicable, participate in cross-functional protocol design and review discussions
Where applicable, advise internal and external partners on choice of statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results
Lead the gathering, organization, and analysis of different data sources to enable delivery of special projects and/or the statistical analysis plan and clinical study endpoints for assigned products
Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring

Skills

Biostatistics

Statistical Analysis

Clinical Trial Design

Sample Size Calculation

Statistical Analysis Plans

NDA Submissions

Regulatory Filings

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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