Associate Director – Biostatistical Programming
Location: Hyderabad, India
Company: Amgen
Department: Global Statistical Programming (GSP)
Employment Type: Full-Time | On-Site
Job Summary
Amgen is seeking an experienced and strategic Associate Director – Biostatistical Programming (Programming Execution Lead) to provide leadership for Global Statistical Programming execution across high-priority clinical development programs and regulatory submissions.
This role partners closely with Global Programming Leads (GPLs) and oversees a large offshore statistical programming organization consisting of Study Lead Programmers (SLPs) and Statistical Programmers (SPs). The Associate Director is accountable for the successful execution, quality, compliance, and delivery of programming activities supporting clinical studies, milestone analyses, and global regulatory submissions.
In addition to operational leadership, the role will drive innovation through the implementation of artificial intelligence (AI), automation platforms, open-source technologies, and advanced programming solutions to enhance efficiency, scalability, and quality across the global programming organization.
Key Responsibilities
Strategic Programming Leadership
Lead end-to-end statistical programming execution for large, high-priority products, therapeutic areas, and global development programs.
Partner with Global Programming Leads (GPLs) to establish and execute programming strategies across assigned products.
Ensure successful delivery of milestone analyses, integrated summaries, and regulatory submission packages.
Drive consistency and quality across studies, indications, and product portfolios.
Global Regulatory Submission Oversight
Provide leadership for programming activities supporting:
NDA Submissions
BLA Submissions
MAA Submissions
Global Health Authority Filings
Ensure submission-ready datasets, analyses, and documentation comply with global regulatory requirements.
Oversee integrated analyses involving multiple studies and development programs.
Operational Excellence & Delivery Management
Accountable for project planning, execution, risk management, and delivery oversight.
Monitor project progress and proactively resolve operational challenges.
Establish delivery metrics and performance indicators to drive operational excellence.
Ensure adherence to timelines, quality standards, SOPs, and compliance requirements.
People Leadership & Talent Development
Lead and manage a large offshore statistical programming team.
Develop organizational capabilities through mentoring, coaching, and succession planning.
Support career development planning for direct reports and project team members.
Foster a culture of accountability, innovation, collaboration, and continuous improvement.
Resource & Budget Management
Partner with GPLs to develop product-level resource strategies.
Forecast staffing requirements and optimize resource allocation across projects.
Contribute to budget planning and operational resource management.
Monitor utilization and productivity across programming teams.
Technology Innovation & Digital Transformation
Lead the adoption and integration of:
Artificial Intelligence (AI)
Statistical Programming Automation
Open-Source Technologies
Digital Delivery Platforms
Advanced Analytics Solutions
Drive modernization initiatives that improve efficiency, quality, and scalability.
Evaluate emerging technologies and identify opportunities for implementation across Global Statistical Programming.
Standards, Governance & Compliance
Develop, review, and implement:
Policies
Standard Operating Procedures (SOPs)
Controlled Documentation
Programming Standards
Ensure compliance with:
CDISC Standards
Regulatory Requirements
Internal Quality Frameworks
Represent Global Statistical Programming during inspections, audits, and regulatory assessments.
Cross-Functional Leadership
Collaborate with:
Biostatistics
Clinical Development
Data Management
Regulatory Affairs
Medical Writing
Clinical Operations
Quality & Compliance Teams
Participate in enterprise-wide working groups and strategic initiatives.
Serve as a key stakeholder in cross-functional governance forums.
Technical Leadership
Provide expert-level guidance on:
Statistical Programming Methodologies
Clinical Trial Data Standards
Submission Strategies
Data Quality & Compliance
Support complex programming challenges and critical project deliverables.
Establish best practices for global statistical programming execution.
Required Qualifications
Education
Bachelor's Degree (BA/BSc) or higher in:
Statistics
Biostatistics
Mathematics
Computer Science
Data Science
Related Quantitative or Scientific Discipline
Experience
Minimum 16+ years of Statistical Programming experience within:
Pharmaceutical Industry
Biotechnology Industry
Clinical Research Organizations (CROs)
Extensive experience supporting global clinical development programs.
Proven leadership experience managing large statistical programming teams.
Demonstrated success leading complex global regulatory submissions.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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