Senior Manager – Biostatistical Programming (Programming Execution Lead)
Department: Global Statistical Programming (GSP)
Location: Hyderabad, India
Company: Amgen
Job ID: R-245754
Work Model: On-site
Experience: 8–15+ Years
Education: B.Sc./M.Sc./M.Tech./PhD in Statistics, Biostatistics, Mathematics, Computer Science, or related quantitative discipline
Role Summary
The Senior Manager – Biostatistical Programming serves as the Programming Execution Lead responsible for leading offshore statistical programming teams supporting global clinical development programs.
The role partners closely with the Global Programming Lead (GPL) to ensure successful execution of statistical programming deliverables, regulatory submissions, clinical trial analyses, and programming strategy implementation across one or multiple therapeutic areas.
This position combines technical leadership, people management, regulatory expertise, project oversight, and digital innovation to drive successful drug development outcomes.
Key Responsibilities
1. Global Statistical Programming Leadership
Lead and oversee end-to-end statistical programming activities across assigned products and studies.
Ensure timely delivery of:
Analysis Datasets (ADaM)
SDTM Datasets
Tables, Listings & Figures (TLFs)
Regulatory Submission Deliverables
Clinical Study Reporting Outputs
Partner with Global Programming Leads to align execution strategies.
2. Regulatory Submission Support
Lead programming activities supporting:
NDA Submissions
BLA Submissions
EMA Submissions
Global Regulatory Filings
Ensure compliance with regulatory requirements and submission standards.
Support audit and inspection readiness activities.
3. Study Execution & Portfolio Oversight
Monitor progress across multiple studies and product programs.
Manage timelines, risks, dependencies, and resource allocation.
Ensure high-quality deliverables are completed within agreed timelines.
Drive resolution of project-level issues and escalations.
4. Statistical Programming Strategy
Implement and maintain:
Programming standards
Functional standards
Data standards
Automation frameworks
Ensure consistency across programs and therapeutic areas.
Promote standardization and scalability across programming activities.
5. Team Leadership & People Management
Lead and develop teams of:
Study Lead Programmers (SLPs)
Statistical Programmers (SPs)
Offshore Programming Resources
Conduct performance reviews and career development planning.
Mentor and coach programming staff.
Build and strengthen high-performing programming teams.
6. Resource Planning & Budget Management
Contribute to:
Workforce planning
Resource forecasting
Budget planning
Capacity management
Optimize resource utilization across programs and projects.
7. Process Excellence & Continuous Improvement
Lead process improvement initiatives.
Participate in cross-functional working groups.
Develop and enhance:
SOPs
Policies
Controlled Documents
Best Practice Frameworks
Drive operational efficiency and quality improvements.
8. Digital Transformation & Innovation
Support adoption of:
SAS Automation
R Programming
Python-Based Analytics
AI-Assisted Programming
Advanced Data Visualization
Drive modernization of statistical programming processes.
9. Cross-Functional Collaboration
Collaborate closely with:
Biostatistics
Clinical Data Management
Clinical Operations
Medical Writing
Regulatory Affairs
Data Standards Teams
Global Clinical Development Teams
Ensure alignment of programming activities with study objectives and regulatory expectations.
Key Performance Indicators (KPIs)
Regulatory submission success
On-time delivery of programming milestones
Quality metrics and audit outcomes
Team productivity and engagement
Resource utilization efficiency
Process improvement contributions
Stakeholder satisfaction
Inspection readiness
Required Qualifications
Education
Mandatory
Bachelor's Degree in:
Statistics
Biostatistics
Mathematics
Computer Science
Related Quantitative Discipline
Preferred
MSc / M.Tech / PhD in Statistics, Biostatistics, Mathematics, or related field
Required Experience
Minimum 8+ years of Statistical Programming experience in Clinical Development.
Experience leading global programming teams.
Regulatory submission experience (NDA/BLA/EMA).
Experience managing multiple studies or product portfolios.
Prior people management and project leadership experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Kfar Saba | Be'Er Sheva | Tel Aviv | Yavne | Netanya |Remote :
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King Abdullah Economic City | Rabigh | Jeddah | Riyadh | Khulais | Najran |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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