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Principal Statistical Programmer
Principal Statistical Programmerprinceps technologies • Republic Of India, IN
Principal Statistical Programmer

Principal Statistical Programmer

princeps technologies • Republic Of India, IN
1 day ago
Job description

Job Title : Senior Statistical Programmer

Location : India

Employment Type : Full-Time

Overview

We are seeking an experienced Senior Statistical Programmer to support end-to-end clinical programming activities across multiple studies. This role requires strong technical proficiency, autonomy, and the ability to collaborate effectively within cross-functional and global teams.

Core Responsibilities

  • Program, validate, and maintain clinical trial datasets and outputs using SAS and R.
  • Lead and execute the full spectrum of statistical programming deliverables, including :
  • Creation and review of SDTM and ADaM specifications
  • Development of SDTM and ADaM datasets
  • TLF (Tables, Listings, Figures) programming
  • Preparation of Define.Xml and reviewer’s guides
  • Develop, enhance, and maintain macros to support study and project requirements.
  • Work independently with minimal oversight, ensuring timely and high-quality deliverables.
  • Demonstrate a strong sense of ownership and accountability for assigned tasks.
  • Communicate proactively with internal teams, providing clear updates and technical guidance.
  • Identify opportunities for process improvements and contribute suggestions to strengthen team efficiency.
  • Proven experience working on oncology clinical trials, with a strong understanding of oncology-specific endpoints and data structures.
  • Participate actively in programming meetings, cross-functional discussions, and knowledge-sharing sessions.

Preferred Qualifications

  • Prior experience working in global or geographically distributed teams.
  • In-depth knowledge of CDISC standards and regulatory submission requirements.
  • Experience supporting FDA and PMDA submissions.
  • Ability to manage multiple studies simultaneously and prioritize tasks effectively.
  • Strong documentation, planning, and organizational skills.
  • Experience mentoring or providing technical oversight to junior programmers.
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    Statistical Programmer • Republic Of India, IN

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