Biostatistical Programming Senior Associate
Company: Amgen
Location: Hyderabad, India
Department: Clinical / Biostatistics & Statistical Programming
Job Type: Full-Time
Work Mode: On-Site
JOB OVERVIEW
The Biostatistical Programming Senior Associate is responsible for performing advanced statistical programming activities to support clinical trial data analysis, regulatory submissions, and drug development programs. The role involves developing and validating SDTM and ADaM datasets, creating Tables, Listings, and Figures (TLFs), preparing programming specifications, ensuring CDISC compliance, supporting regulatory submissions, and collaborating with global cross-functional teams to deliver high-quality statistical programming solutions.
KEY RESPONSIBILITIES
Statistical Programming
Develop and validate SAS and/or R programs for clinical trial data analysis.
Perform statistical programming for efficacy and safety analyses.
Develop reusable programming macros and utilities.
Support programming activities across multiple clinical studies.
Deliver high-quality programming outputs within project timelines.
Clinical Data Analysis
Analyze clinical trial data using SAS and R.
Generate statistical outputs for clinical studies.
Perform data manipulation and transformation.
Support exploratory and ad-hoc analyses.
Ensure accuracy and consistency of analytical outputs.
Clinical Dataset Development
Create and validate SDTM datasets.
Develop ADaM analysis datasets.
Generate analysis-ready datasets for statistical evaluation.
Maintain compliance with CDISC standards.
Validate datasets for regulatory submissions.
Tables, Listings & Figures (TLFs)
Develop and validate Tables, Listings, and Figures (TLFs).
Produce safety and efficacy outputs.
Perform quality review of statistical outputs.
Ensure consistency between datasets and reports.
Support publication-quality statistical reporting.
Regulatory Submission Support
Prepare statistical programming specifications.
Develop programming documentation for regulatory submissions.
Maintain validation and tracking documentation.
Support submission packages for global regulatory agencies.
Ensure compliance with submission standards and regulatory requirements.
Data Quality & Validation
Develop programs for clinical data quality checks.
Validate datasets and statistical outputs.
Perform compliance and consistency checks.
Support issue identification and resolution.
Maintain high standards of programming quality.
Cross-Functional Collaboration
Collaborate with Biostatistics, Clinical Data Management, and Clinical Operations teams.
Work with global study teams across therapeutic areas.
Support Study Lead Programmers (SLPs).
Serve as backup Study Lead Programmer when required.
Participate in project planning and technical discussions.
Standards & Compliance
Implement CDISC SDTM, ADaM, and Define standards.
Follow SOPs and programming best practices.
Ensure compliance with regulatory and company requirements.
Support continuous process improvements.
Contribute to programming standardization initiatives.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree or higher in:
Biostatistics
Statistics
Mathematics
Computer Science
Data Science
Life Sciences
Or a related quantitative discipline
Preferred
Master's Degree (M.Sc.) or higher in:
Statistics
Biostatistics
Mathematics
Computer Science
Related quantitative field
EXPERIENCE REQUIREMENTS
Required
Minimum 4 years of experience in:
Statistical Programming
Clinical Trial Programming
SAS Programming
Clinical Data Analysis
Pharmaceutical or Biotechnology Industry
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