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 ScienceMinimum of 4 years of clinical programming experience using SASLead experience overseeing other programmers and projectsHands-on experience with CDISC, SDTM and ADaM standardsCRO experience preferredKnowledge of Pinnacle 21Strong organizational skills and high accuracy with timelinesStrong verbal and written communication skillsStrong leadership and ability to multitask in a fast-paced environmentDemonstrated experience in statistical programming (SAS preferred) in the Pharma / Biotech industryKnowledge of FDA / ICH regulations and guidelinesCooperative, team-oriented, self-motivated and detail-orientedEducation levels
B.Sc. or MSc. in Statistics (preferred) or related fieldSeniority level
Mid-Senior levelEmployment type
Full-timeAbout 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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