Senior Manager, Statistical Programming

Biopharma Careers; San Francisco (CA); Hybrid; USD 146,000 - 219,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. in Foster City, CA or Raleigh, NC seeks a Sr Manager, Statistical Programming to lead the programming work for study reports and integrated summaries in support of regulatory, scientific and business objectives.

This hybrid role requires collaboration with Clinical Development, generating tables, figures and listings, and ensuring quality and regulatory compliance for FDA and global submissions.

Qualifications

• BS in Biostatistics/Computer Science or equivalent with 8+ years in pharma/biotech.
• MS in Biostatistics/CS or equivalent with 4+ years in pharma/biotech.
• PhD in Biostatistics/CS or equivalent with 2+ years in pharma/biotech.

Responsibilities

• Collaborate with Clinical Development to meet study deliverables.
• Oversee programming deliverables for study reports and integrated summaries.
• Direct design and coding of analysis files.
• Ensure documentation aligns with departmental procedures.
• Provide primary and secondary programming support.
• Support strategic initiatives and regulatory submissions.

Skills

SAS Macros

CDISC standards

Clinical programming

Regulatory submissions

Education

BS in Biostatistics/Computer Science

MS in Biostatistics/CS

PhD in Biostatistics/CS

Tools

SAS Software

CDISC SDTM/ADaM

Clinical Data Management Systems

Job description

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 a Sr Manager, 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.

Key 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, figures, listings) for study reports and integrated summaries.
• Anticipates resource needs
• Directs the design and/or coding of analysis files.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Provides primary and secondary programming support as needed.
• Implements strategic initiatives.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Solid analytical skills with advanced knowledge of statistics
• Proven track record on multiple, time-sensitive, and complex tasks
• Has a thorough understanding of clinical trials design and reporting processes, as well as regulatory reporting requirements including electronic data submissions for multiple therapeutic areas, especially with FDA, PMDA, EMA, and other global agencies.
• Experience with integrated analysis activities for FDA and rest of world submissions plus their post-filing activities.
• Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
• Has the ability to resolve study related issues and conflicts within a therapeutic project.
• Can create buy-in and support and can negotiate timelines.

Basic Qualifications:

• BS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech -OR -
• MS degree in Biostatistics/Computer Science or equivalent and 4+ years’ experience in pharma/biotech –OR -
• PhD degree in Biostatistics/Computer Sciences or equivalent 2+ years of experience in pharma/biotech

Preferred Qualifications:

• Degree in Biostatistics/Computer Science or equivalent
• 8+ years of pharmaceutical/CRO experience
• Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred.
• Knowledge of submission knowledge strongly preferred
• Hands-on experience in pivotal studies and regulatory submissions (NDA, BLA, MAA, etc.)
• 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

Salary Range

Bay Area: $169,320.00 - $219,120.00.

Raleigh: $146,200.00 - $189,200.00.

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: 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.

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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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.