Senior Statistical Programmer (Oncology)

Job Title: Senior Statistical Programmer (Oncology)

Location: India

Employment Type: Full-Time

Experience Required: 8+ Years

Overview

We are seeking an experienced Senior Statistical Programmer (Oncology) to support end-to-end clinical programming activities across oncology studies. This role requires strong technical proficiency, the ability to work independently, and effective collaboration 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 reviewers 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.