Gileadhot

Assoc Director, Statistical Programming

United States - California - Foster City · Director

Sponsorship not specified$196k-$253kDetected 4 days ago

GCPData AnalysisProcess ImprovementClinical TrialsFDA RegulatorySASCommunicationCollaborationProblem SolvingBiostatistics

About the role

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.
We believe every employee deserves a great leader.
People Leaders are the cornerstone to the employee experience at Gilead and Kite.

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.
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.
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.
Identifies and leads strategic initiatives for the programming group.
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 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.
We promote and support individual differences and diversity of thoughts and opinion.
Join Gilead and help create possible, together.

PhD degree in Biostatistics/Computer Sciences or equivalent 3+ years of experience in pharma/biotech
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 -
Excellent verbal and written communication skills and interpersonal skills are required.
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).

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
Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)

include company-sponsored medical, dental, vision, and life insurance plans*.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
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.

We are in search of an Associate Director, Statistical Programming to join our team!
Statistical Programming-
At Gilead, we're creating a healthier world for all people.
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.
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.

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@gilead.com for assistance.

This listing is sourced directly from Gileadhot's careers page and normalized into a canonical job model.