Senior Manager, Clinical Programming (Reporting)

Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Sr. Manager, Clinical Programming (Reporting) will be responsible for overseeing all aspects of data review reporting and data steward activity support for Kite’s clinical development programs with guidance from the Data Management Staff.

This position will be responsible for clinical programming activities (e.g., data review programming, global macros, standard compliance, data extract to data repository) for Kite’s clinical development programs with guidance from the Clinical Data Management Staff and assisting with the technical aspects of clinical data review and the flow of data to the data repository. The Sr. Manager, Clinical Programming (Reporting) will also be responsible for data reporting work on detailed data review for clinical trials. This role will be the representative to provide guidance and technical solutions for studies as well as participate in technical initiatives.

Responsibilities (include but are not limited to):

• Support the management of multiple studies and across therapeutic areas and/or indications
• Lead programmer supporting Data Review programming activities (e.g., Review Data Review Plan, develop SAS, reporting tool listings, including validation)
• Develop, maintain and/or validate standard and study specific listings (e.g., SAS edit checks, reporting tool listings) for studies.
• Develop, maintain and/or validate external data reconciliation programs.
• Lead and support CDM on Study timeline, database snapshot coordination and lock activities to ensure programming deliverables are met
• Develop new programs to assist with data review and cleaning as requested.
• Lead other clinical programming activities (e.g., SAS, J-Review, Business Objects, Tableau) tasks as needed.
• Lead and/or participate in study team meetings and provide technical expertise (EDC, J-Review, Business Objects) and support as needed
• Data Stewardship Lead for all study clinical data
• Lead/participate in process improvement initiatives (including drafting SOPs, WRK) to ensure efficiencies and high quality embedded in the clinical Manage EDC vendor for any issue resolution
• Lead/participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes
• Direct responsibility for supervising and training clinical programmers in the performance of their duties
• Ensure that programming best practices are adhered to.
• Ensure consistency, adherence to standards and governance across all studies
• Resolve problems as they arise within defined procedures and escalate, if necessary, at appropriate time
• Lead/Participate in programming team meetings when appropriate
• Lead representative for programming responsibilities during internal audits as well as Health Authority audits
• Internal team leader who proposes best course of action
• Lead assessment, and monitor project priorities/timelines
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
• Monitor projects to ensure that SOPs are properly followed, and documentation is available
• Build networks to achieve influence with other functions and represent as Programming technical expert
• Prioritize and delegate, if applicable, effectively study and initiative responsibilities
• Continually expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
• Routinely interface with cross-functional team members during all study phases (e.g. study startup, conduct and close out)
• Support with proposals of department strategy and model
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.

Basic Qualifications

• PhD in life sciences or related discipline OR
• MS/MA in life sciences or related discipline and 6+ years of experience in Data Management OR
• BS/BA in life science or related discipline and 8+ years of experience in Data Management OR
• High School degree and 12+ years of experience in Data Management

Preferred Qualifications

• Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management.
• 8+ years programming or other programming language within Clinical Data Management (e.g., SAS, J-Review, Business Objects, Tableau, Spotfire).
• Experience working with Medidata RAVE outputs.
• Excellent verbal and written communication skills.

The salary range for this position is: $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.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com 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
PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 jobs in France:

Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com