The SAS Programmer, as part of the Data Management Functional group, is responsible for data exploration, analyses and reporting in support of drug development and regulatory filings. Excellent interpersonal skills with strong scientific knowledge and SAS programming skills (in SAS/Base, SAS Macros, SAS/STAT and SAS/Graph) are required. Incumbent will work closely with project teams and members to assure quality data and meeting tight deliverable timelines.
- Working with clients to gather requirements
- Designing, coding and executing of SAS codes used to analyze, graph and reporting analytical data for data exploration and regulatory submissions
- Providing documentation of programs and projects adhering to regulatory and company standards
- Developing of SAS edit checks for data cleaning
- Performing standard statistical analyses for shelf-life estimation
- Extracting and merging data to generate standard CMC CTD data tables
- Performing ad-hoc data reporting e.g. statistical analyses, metrics, plots
- Adhering to SOPs and GMP regulations
- Managing project timeline and deliverables for regulatory filings and responses
- A Bachelor's degree in Science/Statistics/Mathematics or related field is required, preferably higher degree
- Over 5 years programming experience with analytical or clinical trial data and preparing programming and testing documentation is required
- Prior work experience with Pharmaceutical industry is desirable
- Good understanding of system development life cycles, GMP, and related regulatory guidelines
- Proven ability to work collaboratively in a very dynamic organization with minimum supervision with good judgment and sound decision making skills
- Detail oriented with strong analytical and problem solving skills
- Ability to manage time and tasks in an organized and professional manner.
- Excellent verbal and written communication skills
- Knowledge of other statistical tools and data visualization tools (e.g. Spotfire) is desirable
Endevis, LLC. and all companies represented are Equal Opportunity Employers and do not discriminate against any employee or applicant for employment because of age, race, color, sex, religion, national origin, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.