Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- 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 CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
- Attending multi-disciplinary team meetings, representing the programming function.
- Develop software systems to generate displays of clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies.
- Assist statisticians by suggesting algorithms to address Client 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.
- Provide time and resource estimates for project planning.
- Oversee work of internal contract programmers and external vendors.
Requirements:
- Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; master's degree preferred.
- Minimum 6 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.