Manager, Statistical Programming - United States
The Clinical Programming Group within the Department of Bio statistics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.
- Attend multidisciplinary team meetings, representing the 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.)
- Create or review and approve CDIS Ccompliant datasets and corresponding documentation for electronic submission to 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.
- Create and maintain department SOPs related to clinical programming.
- 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
- 7 years of experience in developing software for clinical trials using the SAS system
- 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
- Familiarity with CDISC standards, including SDTM and ADaM models
- 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.