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.
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Requirements
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
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
Benefits
Health insurance
Additional Information
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.
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
We are in search of an Associate Director , Statistical Programming to join our team! Statistical Programming- 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.
Gilead Sciences · – Remote