Senior Manager, Statistical Programming Infrastructure and Systems - United States
Want to know company name or location? Company managed [?]
- Responsible for development and maintenance of company'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
Our company is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.