Senior Statistical Programmer

Acldigital; Chennai District; On-site; INR 600,000 - 900,000; Full time

Job summary

A technology solutions company in Chennai is looking for a Statistical Programmer to perform statistical programming reviews and support assigned studies. The ideal candidate will have an MS in Computer Science or related fields, experience in statistical programming, and strong regulatory knowledge. This role involves ensuring quality control and maintaining documentation as per regulatory standards.

Qualifications

• Experience with statistical programming review and analysis dataset specifications.
• Knowledge of CDISC Therapeutic standards and ICH guidelines.
• Ability to manage risks and communicate effectively with project stakeholders.

Responsibilities

• Perform statistical programming review of project documentation.
• Provide statistical programming support for assigned studies.
• Communicate status of tasks to Study Lead Programmer.

Skills

Statistical programming

Quality control

Regulatory compliance

Education

MS in Computer Science

B.E in Computer Science

M.Sc in Microbiology

M.Sc in Statistics

Job description

Qualifications

MS/M.Sc(Science) (Computer Science), B.E (Computer science), M.Sc Microbiology, Master of Science (M.Sc) Statistics

Job Description

• Perform statistical programming review of case report forms (CRFs), annotated CRFs, database structures, statistical analysis plan (SAP) project documentation such as Statistical Analysis Plan (SAP), mock shells, programming specifications and annotated CRFs
• Provide the statistical programming support for assigned studies, in both production and QC of analysis dataset specifications, analysis datasets, statistical analysis tables, data listings, figures, and statistical appendices
• Provide the status of assigned tasks to Study Lead Programmer and Project Manager
• Identify, communicate, and manage study-based risks and issues
• Maintain supporting documentation for studies in accordance with SOPs, Work Instructions (WI) to ensure traceability and regulatory compliance
• Contribute to development of Statistical Programming standards and processes to improve quality, efficiency, and effectiveness
• Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
• Adhere learning and develop knowledge on the latest in CDISC Therapeutic standards, GCP and applicable ICH guidelines