Two95 International Inc. is looking for a Senior/Principal Statistical Programmer for a long-term contract. In this fully remote role, you will own end-to-end statistical programming for clinical trials, with a focus on CDISC standards, advanced analysis, and regulatory submissions.
What You'll Do
- Perform end-to-end statistical programming for ADaM datasets and Tables, Listings, and Figures (TLFs)
- Provide programming support for ISS, ISE, regulatory submissions, and RTQs
- Implement, validate, and maintain CDISC SDTM and ADaM standards
- Develop and reuse macros, functions, and programming utilities
- Author and apply metadata specifications and derivations
What We're Looking For
- 6–10+ years of statistical programming experience in the clinical domain
- Strong statistical programming expertise in R (at least 1-3+ years)
- Hands-on SAS programming experience
- Solid CDISC (SDTM/ADaM) experience
- Exposure to regulatory deliverables, including TLFs, ISS/ISE, and submissions
Nice to Have
- Working knowledge of SQL and/or Python
- Experience with data reuse, historical trial data, Real-World Data (RWD), biomarker data, and External Control Arms
- Experience in Oncology, Respiratory, or Immunology, along with RWD/RWE exposure
- Experience with RWE oncology datasets (EHR, claims data)
- Building and validating analysis cohorts
- Hands-on experience with survival analysis and propensity score methods
Technical Stack
- R
- SAS
- SQL
- Python
Work Mode
This is a fully remote, long-term contract position open to global candidates.
Two95 International Inc. is an equal opportunity employer.
