Senior Statistical Programmer

1 week ago


Rajkot, India princeps technologies Full time

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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