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Assoc Director, Statistical Programming
Career Insights for Biostatistics Manager / Director
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What they do
A Biostatistics Manager or Director manages a team of statisticians and directs statistical analysis and reporting of health and biology-related data. Analysis may be used for product development at a pharmaceutical company, disease research at a hospital or health policy research at a public health organization. Directs the design of statistical analysis and reviews analysis and findings; may manage regulatory reporting for projects such as clinical trials.
$237,618 / year median in California
Job Description
- working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
Analysis Programming:
Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead's regulatory, scientific and business objectives. This is a HYBRID position at our Foster City, CA OR Raleigh, NC locations. This is NOT a fully remote position.Job Responsibilities:
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, listings) for study reports and integrated summaries. Anticipates resource needs. 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. Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. 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 multiple therapeutic areas with FDA, PMDA, and other global agencies. Has extensive hands-on experience with regulatory submissions including integrated analysis and post-submission activities such as FDA and PMDA filing, RtQs, AdCom preparation, and inspections. Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests). Has the proven ability to anticipate and resolve study related issues and conflicts within a therapeutic project. Proven track record as a key resource on multiple, time-sensitive, and complex tasks Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines. Manages critical deadlines, demonstrates ability to resolve issues, and ensures tasks will be completed within designated timeframe. Identifies and leads strategic initiatives for the programming group.Basic Qualifications:
BS degree in Biostatistics/Computer Science or equivalent and 10+ years' experience in pharma/biotech- OR•MS degree in Biostatistics/Computer Science or equivalent and 8+ years' experience in pharma/biotech•OR•PhD degree in Biostatistics/Computer Sciences or equivalent 3+ years of experience in pharma/biotech
Preferred Qualifications:
Degree in Biostatistics/Computer Science or equivalent 10+ years of pharmaceutical/CRO experience Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred. Submission knowledge is strongly preferred. Extensive hands-on experience in pivotal studies, integrated analysis, and other regulatory submission related activities. In-depth understanding of clinical programming and/or statistical programming processes and standards In-depth understanding of regulatory requirements relevant to statistical programming (e.g.GCP, ICH
) Extensive experience with statistical programming using the SAS software including development and use of SAS Macros Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) Proven experience in complex and fast turnaround programming activities Excellent interpersonal, communication, problem solving, and analytical skills The salary range for this position is:Bay Area:
$195,670.00- $253,220.
Raleigh:
$168,980.00- $218,680.
- . For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.