About The Role
Designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data and meet project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides technical expertise in the development of programming standards and procedures.
Your Contributions (include, But Are Not Limited To)
- Serves as the primary project team representative, delegating work as appropriate
- Generates SDTM domains, ADaM data sets, and Define.xml files; creates specification files for these domains
- Generates analysis data sets, tables, figures, and listings for clinical trial data analysis
- Reviews output across programs for consistency
- Reviews, maintains, and approves study documents per standard procedures
- Provides programming support for supplemental/exploratory analyses and ad-hoc requests
- Programs, tests, and documents global utility programs and tools per standards and validation procedures
- Provides technical expertise in analysis/reporting standards and procedures
- Participates in development/maintenance of departmental procedures and standards
- Performs programming using macro language, advanced data manipulation, and statistical procedures
- Implements data management plans to meet project/protocol deadlines
- Acts as a liaison between clinical management, subcommittees, and project teams
- May train and mentor new programmers
Requirements
- BS/BA in CS, math, statistics, or related + 4+ years biopharmaceutical (or CRO) SAS statistical programming (Base, Stat, Macro, graph), including 3+ years in supervisory/lead capacity; or Masterβs with 2+ years; or PhD with similar experience
- Knowledge of ICH, CDISC, 21 CFR Part 11, FDA guidelines; strong SAS (and R/STAT or similar)
- Strong knowledge of SDTM, ADaM, Define.xml; writing/validating/documenting statistical programs; integrated programming libraries; relational databases
- Strong communication, problem-solving, analytical thinking, project management, organizational skills; detail oriented; meets multiple deadlines with high accuracy/efficiency
Benefits (explicitly stated)
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
- Annual bonus (target 20% of earned base salary) and eligibility for equity-based long-term incentive program