The Principal Statistical Programmer provides high quality programming solutions to support clinical studies in various therapeutic areas. She/he will work closely within a team of SAS programmers and Biostatisticians to support and perform analysis of clinical data.
We are looking for someone who has:
- BA or BSc Degree in Statistics, Math or Computer Science
- Minimum of 4 years’ experience in clinical programming using SAS
- Lead experience overseeing other programmers and projects
- Hands-on experience with CDISC, SDTM and ADaM standards
- CRO experience preferred
- Knowledge of Pinnacle 21
- Strong organizational skills
- High degree of accuracy with timelines and ability to meet deadlines
- Strong verbal and written communication skills
- Strong leadership skills
- Ability to multitask in a fast-paced setting
What you will be doing:
- Act as the Lead Programmer
- Responsible for SDTM package:
- - Author/review/update SDTM specifications
- Program/review SDTM datasets
- Validate SDTM datasets
- Author SDTM reviewer’s guide
- Assess impact of protocol amendments to SDTM deliverables
- In collaboration with Senior/Principal Biostatistician:
- - Update ADaM specifications
- Review and QC ADaM datasets programmed by junior staff
- Review and QC TLFs programmed by junior staff
- Program tables, listings and figures as per SAP for clinical research studies
- Import data from 3rd party clients (e.g. central lab transfers)
- Prepare data exports to be sent to clients
- Perform data checks (quality control) as needed to ensure integrity and accuracy of data displays
- Develop, test, document and maintain a library of SAS statistical macros
- Support CDM group in validation of clinical data
- Undertake project management activities as needed, including managing project team of statistical programmers, ensuring timely completion of deliverables with high quality