- Has excellent understanding of biomarker data flow and biomarker clinical programming process.
- Proven ability to enhance processes and develop innovative utilities.
- Provides support and quality oversight for offshore resources.
- Offers trainings and mentoring to junior programmers.
- Produces or oversees the production of biomarker programming deliverables (e.g., mapped data, data validation outputs like edit checks and reports).
- Ensures programming and corresponding documentation align with departmental procedures.
- Capable of leading and managing multiple concurrent projects.
- Possesses excellent verbal and written communication skills, as well as strong interpersonal abilities.
- Has a deep understanding of clinical trial design, data curation, and validation processes.
- Adept at resolving study-related issues and conflicts.
- Skilled in aligning goals, conveying objectives, and negotiating timelines.
- Knowledge of relational database design, FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) is also required.
- 6 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
- Experience in SAS programming required
- Experience with Python strongly preferred
- Experience with Elluminate data platform preferred
- Oncology experience preferred The salary range for this position is: $130, $168, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
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Manager, Biomarker Clinical Programming - Foster City, United States - Gilead Sciences
Description
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.Job Description
Manager, Biomarker Clinical Programming
Job Description
Will be part of a highly effective team of Biomarker Clinical Programmers. Work collaboratively with Biomarker Clinical Data Associates, Biomarker Statistical Programmers, Bioinformatics, Biomarker Scientists and Biomarker/BioAnalytical Operations to meet project deliverables. Work with internal colleagues, offshore resources, and external vendors to ensure efficient, high-quality production of curated data for downstream use in sample tracking, production of statistical outputs for clinical study reports, biomarker analysis reports in support of Gilead's regulatory, scientific, and business objectives.
Key Skills
Education and Experience
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