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Senior/ Principal Statistical Programmer | Long Term Contract | Remote

3 months, 2 weeks ago
India
Contract
Lead
Data Scientist
Data Science and Analytics
Python R SQL
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TWO95 International

TWO95 International

TWO95 International is a global technology firm that specializes in providing comprehensive enterprise solutions, including BPM, Mobility, Cloud, Analytics, E-commerce, and Social Business, while also focusing on emerging technologies such as Generativ...

Internet Software & Services
51-250
Founded 2009
View All Jobs 45

Description

  • 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.
  • Support analysis work involving data reuse, historical trial data, Real-World Data (RWD), biomarker data, and External Control Arms.
  • Build and validate analysis cohorts when working with RWE and oncology datasets.
  • Apply survival analysis and propensity score methods when required.

Requirements

  • 6–10+ years of experience in statistical programming in the clinical domain.
  • Strong hands-on expertise in R (mandatory), with at least 1–3+ years of R programming experience.
  • Hands-on SAS programming experience is required.
  • Solid CDISC experience, including SDTM and ADaM.
  • Working knowledge of SQL and/or Python is an advantage.
  • Experience with regulatory deliverables such as TLFs, ISS/ISE, and submissions.
  • Experience in Oncology, Respiratory, or Immunology is a strong plus.
  • Experience with Real-World Evidence/Real-World Data (RWE/RWD), especially oncology datasets such as EHR and claims data, is preferred.
  • Exposure to biomarker data and External Control Arms is preferred.

Benefits

  • Remote work arrangement.
  • Long-term contract opportunity.
  • Open salary/rate with candidate to provide compensation requirements.
  • Immediate start or start within 15 days.
  • Opportunity to work on advanced clinical and regulatory programming projects.

Interested in this position?

Apply directly on the company website

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