Statistical Programmer Consultant

Summary

Responsibilities

• Act as the lead programmer for assigned clinical trial(s), and work closely with study statistician, clinical data management, and other functions within the study team to provide expert input and statistical programming support.
• Lead the strategic design, creation, mapping, and validation of comprehensive SDTM and ADaM datasets, ensuring flawless execution of data traceabilities.
• Perform statistical analysis, program and validate Tables, Listings, and Figures (TLFs) using SAS to support Clinical Study Reports (CSRs), Development Safety Update Report (DSUR), ad-hoc requests, and publications.
• Review and ensure high quality of CDISC packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML meeting CDISC standards and regulatory requirements as part of eCTD submission.
• Perform other duties as assigned.

Qualifications

• Bachelor’s, Master’s in Statistics, Biostatistics, Computer Science, Mathematics, or a highly related Scientific discipline.
• 8+ years of statistical programing experience within a bio/pharma company, or clinical research organization (CRO).
• Advanced proficiency in SAS (including complicated data steps, Macro language, and commonly used analysis procedures (e.g., PROC FREQ, PROC REPORT, PROC SQL, and PROC MIXED).
• Comprehensive understanding of CDISC standards and experience generating regulatory package artifacts like define.xml and Reviewer's Guides (cSDRG, ADRG).
• Strong communication, analytical, and problem-solving skills, with excellent time management and the ability to independently manage multiple high-priority projects in a fast-paced environment.
• Excellent interpersonal skills and the ability to collaborate effectively as part of a cross-functional team.
• Demonstrated ability to work independently, communicate proactively, and deliver results effectively in a remote work environment