
Posted 8 months ago
Senior/ Principal Statistical Programmer | Long Term Contract | Remote
AI Summary
Senior/Principal Statistical Programmer responsible for end-to-end statistical programming for clinical trials, developing ADaM datasets, TLFs, and regulatory submissions using R and SAS.
About this role
Requirements
We are looking for Senior / Principal Statistical Programmer(s) with strong hands-on expertise in ** R (mandatory) and SAS **, solid CDISC (SDTM/ADaM) experience, and exposure to regulatory deliverables (TLFs, ISS/ISE, submissions)
Mandatory Skills & Experience:
- 6–10+ years of experience in statistical programming in clinical domain (R/SAS)
- Strong statistical programming expertise in R (at least 1-3+ Years)
- Hands-on SAS programming experience required
- Working knowledge of SQL and/or Python is an advantage
- Experience with data reuse, historical trial data, Real-World Data (RWD), biomarker data, and External Control Arms
Core Responsibilities:
- End-to-end statistical programming for ADaM datasets and Tables, Listings, and Figures (TLFs)
- Programming support for ISS, ISE, regulatory submissions, and RTQs
- Implementation, validation, and maintenance of CDISC SDTM and ADaM standards
- Development and reuse of macros, functions, and programming utilities
- Authoring and application of metadata specifications and derivations
Advanced (Good to have) Experience:
- Experience in Oncology, Respiratory, or Immunology, along with RWD/RWE exposure, is a strong plus.
- Experience with RWE oncology datasets (EHR, claims data)
- Building and validating analysis cohorts
Hands-on experience with survival analysis and propensity score methods
Benefits
If Interested please send your updated resume to:**rehana.j@two95intl.com **and include your rate/Salary requirement along with your contact details with a suitable time when we can reach you. If you know of anyone in your sphere of contacts, who would be a perfect match for this job then, we would appreciate if you can forward this posting to them with a copy to us.
We look forward to hearing from you at the earliest.
Skills
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