Jazz Pharmaceuticals, Inc. Senior Manager, Statistical Programming Infrastructure and Systems in Palo Alto, California
Senior Manager, Statistical Programming Infrastructure and Systems
Palo Alto, California
The Statistical 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 development and maintenance of Jazz’s new SAS Server environment.
Responsible for development and validation of CDISC automation tools
Lead development of software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
Develop software validation procedures and test plans, as necessary.
Create SOPs and Work Instructions for statistical programming development, validation and maintenance processes.
Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
Possibly oversee work of internal contract programmers and external vendors.
Assist in development of standards for time and resource estimates for project planning.
Assist in development of training and onboarding statistical programmers.
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.
Highly skilled in programming with SAS and developing macros. Knowledge of additional programming languages a plus.
Good knowledge of statistics and drug development process
Experience as a lead programmer for complex technical projects
Experience overseeing the work of internal contractors and external vendors (CROs) is a plus
Excellent knowledge of CDISC standards, including SDTM and ADaM models
Solid verbal and written communication skills
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.