Biostatistical Programming Manager
Location: Hyderabad, India
Company: Amgen
Department: Global Statistical Programming (GSP)
Employment Type: Full-Time | On-Site
Job Summary
Amgen is seeking an experienced Biostatistical Programming Manager to lead statistical programming activities across clinical development programs and regulatory submissions. This role will serve as the Study Lead Programmer (SLP) for one or more clinical studies, overseeing end-to-end programming strategy, execution, quality, compliance, and delivery.
The successful candidate will provide technical and operational leadership to a team of statistical programmers while collaborating closely with Biostatistics, Clinical Operations, Data Management, Regulatory Affairs, and cross-functional study teams. This position plays a critical role in delivering high-quality statistical programming outputs that support clinical development and global regulatory submissions.
Key Responsibilities
Study Leadership & Programming Strategy
Serve as the Study Lead Programmer (SLP) for one or multiple clinical studies.
Lead statistical programming activities from study start-up through final reporting and submission.
Define and implement programming strategies to ensure quality, compliance, and timely delivery.
Establish programming scope, deliverables, and resource plans in collaboration with statisticians and study teams.
Develop detailed project timelines and monitor execution against milestones.
Statistical Programming & Data Standards
Lead the development and maintenance of:
SDTM Specifications
ADaM Specifications
Define.xml Documentation
Analysis Datasets
Tables, Listings, and Figures (TLFs)
Ensure compliance with CDISC standards and regulatory requirements.
Perform hands-on programming for complex analyses and high-priority deliverables.
Support integrated analyses involving multiple studies and submission packages.
Regulatory Submission Support
Support global regulatory submissions and health authority requirements.
Ensure programming deliverables meet submission-ready standards.
Coordinate programming activities across multiple studies within a product program.
Maintain consistency of datasets and outputs across development programs.
Cross-Functional Collaboration
Represent Global Statistical Programming at Clinical Study Team (CST) meetings.
Participate in study start-up activities, including:
CRF Development
Database Design Review
IVRS/IWRS Specification Review
Data Quality Planning
Database Validation Activities
Collaborate with:
Biostatistics
Clinical Operations
Data Management
Regulatory Affairs
Medical Writing
Safety Teams
Team Leadership & Resource Management
Lead and mentor statistical programmers across assigned studies and projects.
Allocate programming assignments and monitor workload distribution.
Provide technical leadership and programming guidance.
Support capability development, coaching, and knowledge sharing.
Conduct training sessions on programming standards, tools, and best practices.
Project & Quality Management
Manage multiple studies and programming projects simultaneously.
Coordinate data issue identification, tracking, and resolution.
Ensure adherence to SOPs, regulatory guidelines, and quality standards.
Implement risk mitigation strategies to maintain project timelines.
Drive continuous process improvements and automation initiatives.
Technology & Innovation
Promote adoption of modern programming approaches and automation solutions.
Support the use of emerging technologies including:
R Programming
Python
Statistical Automation Tools
Data Quality Platforms
Contribute to digital transformation initiatives within statistical programming.
Required Qualifications
Education
Bachelor's Degree (BSc/BA) or higher in:
Biostatistics
Statistics
Mathematics
Computer Science
Data Science
Related Quantitative or Scientific Discipline
Experience
Minimum 8+ years of Statistical Programming experience within Clinical Development, CRO, Biotechnology, or Pharmaceutical industries.
Prior experience leading end-to-end programming activities for clinical studies.
Experience managing statistical programmers and project deliverables.
Experience supporting global clinical trials and regulatory submissions.
Uttar Pradesh :
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