ClinicalSASprogrammer
ClinicalSASprogrammer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Attending multidisciplinary team meetings representing the programming function.
- Create or review and approve programming plans at study and project level.
- Provide input on key studyrelated documents produced by other functions (e.g. CRFs Data Management Plan SAPs etc..
- Create or review and approve CDISCcompliant datasets and corresponding documentation for electronic submission to regulatory agencies.
- Develop software systems to generate displays of clinal all 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.
- Oversee work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
- Bachelors degree in computer science Statistics Mathematics Life Sciences or other relevant scientific fields; masters degree preferred.
- Minimum 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.
Employment Type
Full Time
