Overview
Our client SCiAN Services is looking for a Principal Statistical Programmer to provide high quality programming solutions to support clinical studies across various therapeutic areas. The person will work closely with a team of SAS programmers and Biostatisticians to support and perform analysis of clinical data.
Responsibilities
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
Collaborate with Senior / Principal Biostatistician to update ADaM specifications and review / QC ADaM and 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) and prepare data exports for clients
Perform data checks (quality control) to ensure data integrity and accuracy
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 and ensuring timely, high-quality deliverables
Qualifications
B.A. / B.S. in Statistics, Mathematics or Computer Science
Minimum of 4 years of clinical programming experience 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 and high accuracy with timelines
Strong verbal and written communication skills
Strong leadership and ability to multitask in a fast-paced environment
Demonstrated experience in statistical programming (SAS preferred) in the Pharma / Biotech industry
Knowledge of FDA / ICH regulations and guidelines
Cooperative, team-oriented, self-motivated and detail-oriented
Education levels
B.Sc. or MSc. in Statistics (preferred) or related field
Seniority level
Mid-Senior level
Employment type
Full-time
About SCiAN
SCiAN has 34 years in the Biotechnology / Pharmaceutical Industry, offering services in Pharmacovigilance, Biostatistics, Data-Management, and other custom-database solutions.
Equal Opportunity
We are an equal opportunity employer and support diversity in our workplace.
Experience
SCiAN has been part of the Biotechnology / Pharmaceutical Industry for 34 years. We offer services in Pharmacovigilance, Biostatistics, Data-Management, as well as other custom-database solutions.
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Programmer • Toronto, Canada