Assoc Director, Statistical Programming

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 DescriptionWe 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. 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 tasksProven 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 - $253,220.00.Raleigh: $168,980.00 - $218,680.00.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*.For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.For jobs in the United States:Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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 View email address on click.appcast.io for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead 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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.SummaryLocation: United States - California - Foster CityType: Full time