Associate Director, Biostatistics – Virology Key Responsibilities Acts as biostatistics lead on clinical studies or other non‑molecule projects. Leads statistical analysis, document review, and data inclusion for submissions, collaborating with other Biostatistics team members and cross‑functional partners; provides consultation on trial design and study endpoints; 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 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; advises on analysis strategies, reliability of measurements, model identifiability, interpretation and presentation of results. Leads gathering, organization and analysis of different data sources to deliver special projects, statistical analysis plans, or clinical study endpoints. Reviews and analyzes safety reporting, biomarker analyses, and other aspects of trial monitoring. Uses advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development. Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry. Develops enhancements to statistical software as appropriate, including programming new techniques; stays informed of emerging trends and tools. Provides biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation. May participate in or lead special projects that benefit multiple Biostatistics team members, develop or implement SOPs, and related documentation. Provides matrix management to supported projects. Independently defines required resources for assigned work, seeking advice as needed. Adheres to regulatory requirements, statistical analysis principles, industry standards, and Gilead SOPs. Basic Qualifications Bachelor's degree and 10 years of experience Master's degree and 8 years of experience PhD degree and 5 years of experience Preferred Qualifications Advanced knowledge of biomedical statistical analysis; demonstrated independence in designing, implementing, and managing multiple statistical analysis strategies and deliverables. Experience developing software and tools to support statistical analysis of biomedical data using R/Shiny; strong proficiency in typical Biostatistics tools. Advanced knowledge of biostatistics best practices and tools; ability to apply to improve results. Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes. Understanding of drug development phases and associated clinical trials. Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures. Strong communication and organizational skills. Proven effectiveness managing projects and teams. When needed, ability to travel. People Leader Accountabilities Create Inclusion – model diversity and embed the value of diversity in team management. Develop Talent – coach employees on current performance and future potential; provide feedback and insight for growth. Empower Teams – align team goals with organizational objectives; remove barriers and connect teammates to broader ecosystem. Compensation and Benefits Salary range: $195,670.00 – $253,220.00. Base compensation may vary based on experience, qualifications, and geographic location. Eligible for discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. Additional benefits may be available subject to plan terms and conditions. Equal Employment Opportunity Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprising diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@ for assistance. Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. #J-18808-Ljbffr
Associate Director, Biostatistics - Virology. Job In San Mateo Lilylifestyle Jobs
UNITED CEREBRAL PALSY OF GEORGIA
san mateo, san mateo
Published 4 days ago
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