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Two95 International Inc.

Senior/ Principal Statistical Programmer | Long Term Contract | Remote

Reposted One Month Ago
Be an Early Applicant
In-Office or Remote
3 Locations
Senior level
In-Office or Remote
3 Locations
Senior level
Lead end-to-end statistical programming for ADaM datasets and TLFs; implement, validate, and maintain CDISC SDTM/ADaM standards; support regulatory submissions (ISS/ISE) and RTQs; develop reusable macros/functions and metadata specifications; work with RWD, biomarker data, external control arms, survival analysis, and propensity score methods.
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Title: Senior/ Principal Statistical Programmer(R)

Location: Remote

Duration: Long Term Contract

Salary: Open

Experience : 6-10+ Years

Notice : Immediate OR Within 15days


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:[email protected]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.

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