Senior Manager, Clinical Programming

Teva Pharmaceuticals - West Chester, PA

Full-time - Senior

West Chester, PA

Chemical Manufacturing

About the position

The Clinical Programming Senior Manager at Teva Pharmaceuticals plays a crucial role in managing the timely and accurate execution of programming components of clinical trials. This position involves leading and managing completed projects that require global tasks, cross-functional teams, or outsourcing resources. The Senior Manager is expected to provide inputs to the design and analysis of clinical trials, report results, and ensure compliance with programming rules and standards. Additionally, the role includes providing safety claims for new drugs and supporting the extension of claims and publications for marketed drugs. In this role, the Senior Manager will be responsible for overseeing all major duties of a Clinical Programming Manager, which includes leading global projects that necessitate project management and leadership capabilities. The Senior Manager will supervise or mentor Contract Research Organizations (CROs) or outsourcing programmers, ensuring strong programming support for CDISC-based e-submissions. This includes developing, reviewing, and validating generic macros, as well as debugging and enhancing SAS programs to support quality control of safety or efficacy derived datasets. The Senior Manager must possess a solid understanding of statistical models in efficacy data analysis and implement programming standards while complying with regulatory requirements. They will serve as a core member of the clinical team, acting as the main programming contact with statisticians and project physicians. Responsibilities also include standardizing Biometrics deliverables across study projects within a therapeutic area, coordinating Clinical Programming resources, and participating in project team meetings. The Senior Manager will extend existing or develop new clinical programming methods to address complex problems, ensuring the accuracy and validity of data displays and study databases (SDTM and ADaM). They will be primarily responsible for all programming deliverables for NDA/MAA/IND/PSUR and will work closely with the Statistics group for the production of tables, listings, and graphs as applicable. Mentoring and training associates within the Biometrics group for SAS programming is also a key aspect of this role, along with miscellaneous activities directed by management.

Responsibilities

• Manage the timely and accurate execution of programming components of clinical trials.
• Lead and manage completed projects involving global tasks or cross-functional teams.
• Supervise or mentor CROs or outsourcing programmers.
• Provide strong programming support to CDISC based e-submission.
• Develop, review, and/or perform validation of generic macros.
• Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets.
• Implement programming standards and comply with regulatory requirements.
• Communicate project status and resource issues to management.
• Serve as a core member of the clinical team and main programming contact with the statistician and project physician.
• Standardize Biometrics deliverables across study projects within an indication/therapeutic area.
• Coordinate Clinical Programming resources, priorities, and timelines with the clinical team.
• Participate in project team meetings.
• Extend existing or develop new clinical programming methods to solve complex problems.
• Ensure the accuracy and validity of data displays and study databases (SDTM and ADaM).
• Be primarily responsible for all programming deliverables for NDA/MAA/IND/PSUR.
• Work closely with the Statistics group for the production of tables, listings, and graphs.
• Mentor and train selected associates within the Biometrics group for SAS programming.

Requirements

• Bachelor's or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
• 10+ years of professional experience in pharmaceutical or clinical research.
• Excellent SAS knowledge of Base SAS, SAS report writing, and SAS macros/functions.

Benefits

• Medical coverage starting on the first day.
• Dental coverage starting on the first day.
• Vision coverage starting on the first day.
• Prescription coverage starting on the first day.
• Disability Insurance.
• Life Insurance.
• Paid Time Off.
• Paid Holidays.
• 6% match on the 401(k).
• Employee Stock Purchase Plan.
• Tuition Assistance.