Statistical Programming Lead- Manager (Analysis Oversight)
Role Overview
Clinical Data Science (CDS) is a business unit within Development whose mission is to achieve regulatory approval and successful marketing of new therapies through a reproducible, transparent, efficient, and validated approach to study design, data acquisition, analysis, and interpretation.
Our pursuit is to deliver on unmet medical needs by introducing therapies for life-threatening diseases.
Within CDS, we strive to reach this goal through excellence in data management, analytical methods, and advanced programmatic approaches to gain insights from a wide range of data assets.
To achieve the commitments of our clinical portfolio, CDS has been developing an agile and sustainable resource model that leverages external partnerships to form a strong alliance with internal Gilead roles.
Together, these teams will deliver statistical programming outputs that meet study analysis needs and requirements.
The Analysis Oversight Statistical Programming (AOSP) Lead is essential to these partnerships.
As a member of the Study Management Team (SMT), the AOSP Lead works closely with the study team to determine the statistical programming requirements, understand study milestones and programming dependencies, and leads the development of the programming outputs.
The Analysis Oversight Statistical Programming Lead is accountable for the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables, ensuring completeness, accuracy, and compliance with regulatory and quality standards.
This role will progressively review vendor performance metrics in governance meetings to monitor trends and address any challenges, risks, and/or bottlenecks encountered by the study programming team.
The position requires a strong acumen in statistical analysis, focused on achieving high-quality outputs that support clinical results.
In addition, the candidate will need to perform quality management, coach and mentor programming colleagues, and provide statistical guidance as it relates to specifics of the study and general processes and statistical program education.
The candidate will need to closely monitor the quality and timeliness of clinical trial programming deliverables, provide process guidance, support creation and maintenance of onboarding materials, and direct prioritization and coordination of study related deliverables.
Key Skills for This Role
Full Job Posting
Preferred Qualifications:
- Bachelor's Degree and Seven Years’ Experience ORMasters' Degree and Five Years’ Experience
- Minimum 2 years leading studies in Virology, Oncology, or Inflammation Therapeutic Area
- Mature statistical knowledge and expertise in the development of ADaM and TFLs and dependent tasks/activities.
- Proven track record in delivering high quality statistical programming datasets and outputs.
- Ability to collaborate and work effectively with global team members and build strong relationships.
- Expertise working in global teams, across various time-zones to achieve clinical trial milestones.
- Remains current and has deep knowledge of GCP, ICH guidelines, and regulatory requirements, specifically as it relates to quality oversight, quality assurance, and risk management.
- Ability to problem-solve using data-driven approaches to help determine the best path forward.
- Excellent customer-focus with proven track-record in building relationships through superlative communication and writing skills.
- Superior skills in coaching and mentoring staff of varying skillsets and respectful of cultural differences especially communication styles.
- Results-oriented and able to work closely with others through great collaboration to resolve challenges, bottlenecks, or risks.
- Ability to motivate large diverse teams to achieve a common set of goals.
- Strong experience in data analysis and demonstrated critical thinking skills.
- Strong programming experience in non-compartmental Pharmacokinetics (PK) analysis for various study designs.
- Oversee and guide the development of statistical programs for TQT, cQT, pharmacokinetics (PK), and pharmacodynamics (PD) analysis, ensuring adherence to study protocols and regulatory submissions.
- Able to lead and mentor effective cross functional teams and keep programming team promptly informed of all study activities.
- The salary range for this position is: $146,540.00 - $189,640.00. 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 [email protected] for assistance.
- For more information about equal employment opportunity protections, please view the 'Know 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.
- Please apply via the Internal Career Opportunities portal in Workday.
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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know 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.
About Gilead
Gilead Sciences is a global biopharmaceutical company that discovers, develops and delivers therapies for life-threatening diseases, with a focus on virology, oncology and inflammation.
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