Assoc Director, Statistical Programming

Gilead Sciences

Job Location:

Foster, CA - USA

Monthly Salary: $ 195670 - 253220

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 Gileads 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: $195670.00 - $253220.00.

Raleigh: $168980.00 - $218680.00.

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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. 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.

Required Experience:

Director