Manager, Statistical Programming - United States
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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.