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Manager, Statistical Programming: Job ID
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BridgeBio Pharma, Inc. San Francisco, CA, United StatesAbout BridgeBio BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in geneti ...
Sr. Manager, Statistical 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
Senior Manager, Statistical Programming (Virology)
Location: Foster City, CA
Job Responsibilities and Skills:
Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
Generates or oversees the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries.
Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a Virology therapeutic area project.
May manage a small team of statistical programmers.
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
Directs the design and/or coding of analysis files.
Oversees and is responsible for all pediatric programming activities within a
Virology therapeutic area project or equivalent.
Provides primary and secondary programming support as needed.
Implements strategic initiatives.
Excellent verbal and written communication skills and interpersonal skills are required.
Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions for the Virology therapeutic area pediatric projects, especially with FDA, EMEA, and other global agencies.
Experience with leading FDA NDA submissions and post-filing activities.
Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
Has the ability to resolve study related issues and conflicts within a therapeutic project.
Can create buy-in and support and has the ability to negotiate timelines.
Has the ability to directly supervise personnel.
Manages critical deadlines, demonstrates ability to resolves issues, and ensures studies will be completed within designated timeframe.
Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
Viewed as a key resource by more senior individuals on technical initiatives and may represent the Company on contracts.
Inform functional management programming resources required for the projects.
Recommends and provides trainings.
Serves as project leader.
Participates in cross-functional meetings as a representative of Programming group.
Typical Education and Experience:
8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
2 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.
The salary range for this position is: $165, $214, 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*.