Prin Stat Programmer

Overview

The Principal Stat Programmer ensures the accuracy and integrity of statistical programming across clinical projects, with a focus on SAS programming and CDISC standards (ADaM/SDTM).

What you'll do

• Develop and validate complex datasets and outputs using SAS in compliance with CDISC ADaM and SDTM standards.
• Perform Safety and/or Efficacy analysis programming, including creation of efficacy datasets and outputs (Tables, Listings, Figures).
• Author and review ADaM specifications for Safety and/or Efficacy analyses.
• Create and maintain regulatory submission documentation including ADRG and Define.xml.
• Validate datasets using Pinnacle 21 (P21) to support submission readiness and compliance.
• Provide technical guidance on statistical methodologies and programming best practices, and mentor junior programmers.
• Use R for statistical analyses, automation, data manipulation, reporting, and programming solution development where applicable.

What you'll need

• Minimum 1 year of hands-on R programming experience (mandatory).
• Experience in Safety and/or Efficacy analysis programming (required).
• Hands-on experience creating efficacy datasets and efficacy outputs (Tables, Listings, Figures).
• Experience writing ADaM specifications for Safety and/or Efficacy studies.
• Experience creating ADRG and Define.xml and performing dataset validation using Pinnacle 21 (P21).
• Strong knowledge of CDISC SDTM and ADaM standards.
• Bachelor’s degree in Statistics, Computer Science, or related field; Master’s degree in Statistics or Computer Science is preferred.