Senior Manager, Statistical Programming
The Clinical Programming Group within the Department of Biostatistics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.
- Responsible for all statistical programming activities within a therapeutic project or equivalent
- Lead, manage, develop and support statistical programming team
- Manage critical deadlines, demonstrate ability to problem solving, and ensure quality statistical programming deliverables will be completed within designated timeframe
- Serve as project leader on studies or tasks of greater complexity
- Attend multidisciplinary team meetings, representing the statistical programming function.
- Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
- Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
- Assist statisticians by suggesting algorithms to address novel analysis requests
- Develop software validation procedures and test plans, as necessary
- Create and document archives of software, outputs, and analysis files
- Contribute to the creation and maintenance of department SOPs related to clinical data analysis
- Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately
- Oversee work of internal contract programmers and external vendors
- Provide time and resource estimates for project planning
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life
- Sciences or other relevant scientific fields; Master’s Degree preferred
- Minimum of 10 years of experience in developing software for clinical trials
- using the SAS system, with 3 or more years of supervising SAS programmers.
- Skilled in programming with SAS. Knowledge of additional programming
- languages a plus.
- Good knowledge of statistics and drug development process
- Experience as a lead programmer for NDAs/BLAs
- Experience overseeing the work of internal contractors and external
- vendors (CROs)
- Experience in pharmacokinetics/pharmacodynamics modeling a plus
- Good knowledge with CDISC standards, including SDTM and ADaM
- Solid verbal and written communication skills
Description of Physical Demands
- Occasional mobility within office environment
- Routinely sitting for extended periods of time
- Constantly operating a computer, printer, telephone and other similar office machinery
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
- Frequent computer use at workstation
- May move from one work location to another occasionally
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands
- Occasional public contact requiring appropriate business apparel
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.