
Principal Statistical Programmer FSP - Medical Affairs and Clinical Development
- India
- Permanent
- Full-time
- Write SAS programs that produce tables, listings, figures and analysis datasets ;
- Write SAS programs that validate tables, listings, figures, and analysis datasets;
- Follow good programming practices, including adequately documenting SAS code;
- Use, modify, and maintain existing SAS code;
- Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
- Assist in developing programming processes consistent with industry best practices;
- Review DMP, eCRF specs, and other clinical data management documents;
- Review statistical analysis plans and other related documents;
- Partner with CRO to perform any of the above tasks;
- Perform all the tasks with minimal instruction or input from supervisor
- Review, maintain study documents per standard process
- Program, test, and document global utility macros and tools in accordance with standards and validation procedures
- Perform other duties as assigned
- Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
- Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
- Excellent and transparent communication skills and ability to represent the functional group to across stakeholders
- At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
- Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
- Experience in producing and validating SAS programs;
- Experience in working with CDISC standards, including SDTM, and ADaM;
- Familiarity with statistical analysis for standard clinical trial outputs;
- Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
- Good communications skills required;
- Bachelor's Degree required, Master's Degree Preferred.
- Clear alignment with the Core Values:
- Commitment to People
- Innovation and Discovery
- Sense of Urgency
- Open Culture
- Passion for Excellence