Senior Statistical Programmer

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.