Statistical Programmer
Company: Medtronic
Location: Hyderabad, India
Department: Biostats & Clinical Intelligence (BCI) – Clinical & Regulatory Solutions (MCRS)
Job Type: Full-Time
Work Mode: Remote
JOB OVERVIEW
The Statistical Programmer is responsible for designing, developing, validating, and maintaining statistical programs to support clinical trials, regulatory submissions, and data analysis activities. The role involves SAS programming, clinical data analysis, database development, statistical reporting, data validation, and collaboration with biostatistics, clinical data management, and cross-functional teams to deliver high-quality programming solutions that meet regulatory standards and project timelines.
KEY RESPONSIBILITIES
Statistical Programming
Develop and maintain SAS programs for clinical trial data analysis.
Design, program, test, validate, and document statistical programs.
Create analysis datasets, tables, listings, and figures (TLFs).
Develop reusable programming utilities and macros.
Maintain programming standards and validation procedures.
Clinical Data Analysis
Analyze clinical trial data for regulatory submissions.
Develop analysis datasets from multiple data sources.
Support complex studies, including Premarket Approval (PMA) studies.
Identify and resolve data inconsistencies.
Assist in data cleaning and quality review activities.
Clinical Trial Support
Review Statistical Analysis Plans (SAPs) from a programming perspective.
Support protocol and Case Report Form (CRF) development.
Perform database programming and data manipulation.
Integrate clinical databases from multiple studies.
Support internal and external client deliverables.
Regulatory & Compliance
Ensure compliance with SOPs, GCP, and regulatory requirements.
Validate statistical programs according to company standards.
Support regulatory submissions and inspections.
Maintain complete programming documentation.
Contribute to process improvement initiatives.
Cross-Functional Collaboration
Collaborate with Biostatistics, Clinical Data Management, and Clinical Operations teams.
Coordinate programming activities across projects.
Support project planning and timeline management.
Interact with external clients and vendors when required.
Participate in client meetings and technical discussions.
Leadership & Process Improvement
Mentor junior statistical programmers.
Assist in developing programming training materials.
Support outsourcing partners and vendor oversight.
Contribute to SOP and work instruction development.
Promote programming best practices and process improvements.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree or Advanced Degree in:
Statistics
Biostatistics
Mathematics
Computer Science
Life Sciences
Data Science
Bioinformatics
Or a related discipline
EXPERIENCE REQUIREMENTS
Required
Bachelor's Degree with 2+ years of SAS programming or clinical data programming experience.
OR
Master's Degree with 0+ years of relevant experience.
Preferred
Clinical trial statistical programming experience.
Experience with regulatory submissions (FDA, PMA, CE).
Experience in Clinical Data Management.
Knowledge of SDTM, ADaM, and CDISC standards.
Experience with Tables, Listings, and Figures (TLFs).
Experience supporting biostatistics teams.
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Remote, India | Siliguri |Illinois :
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Netherlands |Remote Australia :
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