Statistical Programmer
Statistical Programmer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- 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.
Requirements:
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
