Senior Statistical Programmer

Job description

Role

Senior Statistical Analyst / Senior Statistical Programmer Educational Qualification / Experience for the role: Master's degree with 6+ years of experience or bachelor's degree with 8+ years of experience in statistics, computer science, engineering, or a related field Required Skillsets:

• Proficiency in SAS / R programming languages to Program and validate ADaM, TFL and statistical analyses
• Proficiency in using statistical software and programming tools
• Understanding of statistical methods, data analysis techniques, and clinical research processes.
• Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
• In-depth understating of drug development process and clinical study life cycle
• Familiarity clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
• Strong experience in generating TLFs, programming macros, and data manipulation using SAS.
• Good to have experience in other statistical programming languages (R).
• Experience working on cross-study, integrated data analysis.
• Strong attention to detail and quality Focus
• Problem-solving skills (Ability to identify and troubleshoot programming issues)
• Effective communication skills (both written and verbal)
• Ability to interact professionally with statisticians, study teams, and external partners
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

Key Responsibilities

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.
• Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
• Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
• Develop and maintain programming documentation, such as ann

Qualifications

BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), M.SC., MASTER OF PHARMACY