Senior Program Manager Jobs

Senior Program Manager

Location: (home-based OR office-based)

United States/Canada

Overview of the role:

The Senior Program Manager, Biostatistics will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of high complexity, and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality, and maintain consistency across studies.

• Preparation of statistical analysis plans (SAP) including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
• Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
• Writing of the statistical methods sections of integrated study reports; reviews draft integrated study reports
• Statistical analysis, Interpretation of data and reporting of results
• Review project database structures, edit checks, and data management coding conventions
• The program of studies will typically lead to a regulatory submission.
• Supports responses to regulatory questions on the design the design of the program, and any labelling claims following submission

To be successful, you will need:

• 10+ years of relevant experience with M.S. OR 8+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the pharmaceutical industry)
• Excellent verbal and written communication skills
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
• Experience leading Phase II and/or Phase III studies
• Prior experience interacting with sponsor/clients
• Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
• Oncology experience is preferred, but not required
• M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)

Benefits:

Our client offers a competitive compensation package inclusive of the following:

Competitive base salary, annual bonus based on company performance, access to healthcare and wellbeing programs, retirement savings program, paid time off, and employee recognition programs which reward exceptional achievements.

If you are looking to take the next step in your career in the Biotech industry and you would like to know more about this role or the other opportunities we currently have on our books, please apply now with your CV to speak with our specialist Scientific Consultant, Seong Yap.