Principal Statistical Programmer

Summary:

The Principal Statistical Programmer provides high quality programming solutions to support clinical studies in various therapeutic areas. They 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 or Math
• Minimum of 7 years’ experience in clinical programming using SAS
• Lead experience overseeing other programmers and projects
• In-depth experience with CDISC, SDTM and ADaM standards in Phase 2 - 3 trials
• Experience using 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 environment

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, and assess impact of protocol amendments to SDTM deliverables
• In collaboration with Principal Biostatistician: update ADaM specifications, program/review ADaM datasets, and review 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
• 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