Role Summary
Senior Statistical Programmer II (Remote) β Provides technical guidance on clinical project teams, focusing on the design, development, and quality control of SAS programs to access, extract, transform, review, analyze, and submit clinical data for individual studies. Participates in departmental and cross-functional technology development and process improvement initiatives.
Responsibilities
- Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDISC SDTM format; consistently meeting study objectives
- Performs quality control checks of SAS code and output produced by other Statistical Programmers
- Demonstrates proficient knowledge of clinical development and medical data
- Solves clinical trial reporting problems and provides technical proficiency in supporting daily operations, ensuring tasks are completed accurately with limited supervision
- Creates CDISC data sets by transforming raw data sources, including EDC databases and IWRS, and reports/submits results of clinical trials for investigational medications
- Works with coding dictionaries (MedDRA and WHODDD) used in the pharmaceutical industry
- Provides technical leadership in a team environment, solving clinical trial reporting problems within budget and timeline constraints while maintaining high quality
Qualifications
- Required: Bachelorβs or Masterβs degree in a Scientific Discipline
- Required: 2+ years for MS or above; 5+ years for BS in Biotech, Pharmaceuticals or Clinical Research Organization
- Preferred: Competence with SAS; working knowledge of CDISC standards and clinical trials
Skills
- Proficiency with SAS
- Working knowledge of CDISC standards
- Working knowledge of clinical trials
- Effective written and verbal communication skills to exchange complex information
Education
- Bachelor's/Master's degree in a Scientific Discipline