Statistical Programmer
Statistical Programmer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Lead the development validation and maintenance of statistical programs using SAS to generate tables listings and figures (TLFs) for clinical trial data analysis.
- Develop and maintain SDTM domains in accordance with CDISC guidance.
- Create and optimize Adam datasets Tables Figures Listings (TFLs) and Analysis content.
- Support the creation of statistical outputs for clinical study reports (CSRs) regulatory submissions and publications.
- Prepare documentation for regulatory submissions including electronic submissions to the FDA and other global health authorities.
- Perform data cleaning validation and preparation tasks to ensure high-quality datasets for analysis.
- Prepare and maintain thorough documentation of programming activities including specifications programming code and validation reports.
- Minimum of a bachelors degree required; MS degree is preferred (statistics biostatistics or closely related field).
- 5 years experience with SAS and clinical programming within the biotech / pharmaceutical industry.
- Proficiency in SAS programming including experience with SAS macro language data step programming and PROC SQL.
- Strong knowledge of CDISC and CDASH standards including SDTM and Adam datasets and experience with regulatory submission requirements.
- Experience with clinical trial data and understanding of the drug development process.
- Knowledge of regulatory guidelines including FDA EMA and ICH related to statistical programming and clinical trials.
- Experience with statistical programming development validation execution maintenance documentation and archival of clinical data for regulatory submission is required.
Employment Type
Full Time
