- R+D/ Global Development Support
- $120-140k +complete benefits package
- Greater Maryland area / Remote
A late-stage biotechnology company is looking to hire a Sr Programmer. The person will lead Vaccine programming activities in Phase I-III.
The Sr Clinical Programmer position will have responsibilities that include:
- Leading programming activities for CSR and regulatory filing related tasks, including SDTM/ADAM and TFL readiness, in Phase I - Phase III clinical trials for seasonal flu and COVID19 vaccines.
- Work together with project statisticians to assist other functional areas to perform statistical analyses or data tabulations of clinical data.
- Support creation and maintain of department SOPs.
- Provide contribution as appropriate into specifications of data structures and database applications to ensure adherence to the standards data storing and management.
- Accountable for quality control and quality audit of SAS software programming deliverables.
- Oversee programming activities by external vendors for outsourced studies and contract programmers.
- Supervise junior programmers and provide guidance.
The ideal candidate will have the following skill set:
- BS degree in Math/Statistics, Computer Science, or medical related field.
- At least 7 years SAS programming experience (Base SAS, SAS/STAT, and SAS macro language) on clinical trial data in biotech/pharmaceutical industry, or in a CRO servicing the pharmaceutical industry.
- At least 5 years SAS programming experiences in creation/validation SAS datasets and TFLs per SAP or Table Shell/Specs for CSR.
- Worked as lead or principal programmer role on Phase II or III studies for at least 2 years.
- Programming experience in producing outputs for periodical safety report such as SRT, DSMB, DSUR or ClinicalTrials.gov, or outputs to support publications in clinical department.
- Familiar with CDISC guidance and be able to independently create CDISC SDTM/ADAM domains, and associated specs, from clinical data.
- Exceptional project management skills, able to work comfortably with tight deadlines.
- Skilled with filing (NDA/BLA) or vaccine clinical trials is preferable.