Clinical SAS Programmer

Philadelphia, PA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

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:

Minimum 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 o...