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Clinical SAS Programmer
cGxPServePhiladelphia, Pennsylvania, USAjob_description.job_card.variable_days_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionMinimum of 5 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.
Responsibilities :
- Attending multi-disciplinary 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 CDISC-compliant 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 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.
Requirements :
Key Skills
Databases,SQL,FDA Regulations,R,Relational Databases,Data Management,Data Structures,Clinical Trials,Statistical Software,CDISC Standards,SAS,Oracle
Employment Type : Full-time
Experience : years
Vacancy : 1
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Programmer • Philadelphia, Pennsylvania, USA