Senior Manager, Biostatistical Programming
Location: Hyderabad, India
Department: Research
Job Overview
The Senior Manager, Biostatistical Programming (Programming Execution Lead) will partner with the Global Programming Lead (GPL) and lead an offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to ensure successful execution of end-to-end programming activities across assigned products and therapeutic areas. This role is accountable for the delivery of statistical programming outputs, milestone analyses, and regulatory submission packages while supporting global programming strategies and operational excellence.
Key Responsibilities
Lead and oversee end-to-end statistical programming activities for assigned products and studies.
Ensure successful execution and delivery of milestone analyses and regulatory submission deliverables.
Collaborate with the Global Programming Lead (GPL) to implement global programming strategies, standards, and industry requirements.
Plan, monitor, and manage project timelines, resources, and deliverables.
Support resource planning, budget management, and allocation of programming staff.
Optimize utilization of programming resources based on business priorities.
Lead and contribute to departmental process improvement initiatives and cross-functional projects.
Support internal and external audits, inspections, and compliance activities.
Develop, review, and implement policies, SOPs, and controlled documents related to Global Statistical Programming.
Provide hands-on programming support when required.
Coach, mentor, and develop programming staff.
Contribute to career development planning and performance management of team members.
Collaborate effectively with global and cross-functional stakeholders across multiple time zones.
Required Qualifications
Bachelor's degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related quantitative/scientific discipline.
Minimum 8 years of statistical programming experience in a clinical development environment.
Strong leadership, communication, and project management skills.
Experience leading programming teams and delivering study outputs from start to finish.
Experience building and managing offshore statistical programming teams.
Advanced expertise in SAS programming, including:
SAS/STAT
SAS Macro
SAS Graph
SAS SQL
Prior experience supporting regulatory submissions for drug approvals.
Strong understanding of data quality processes and compliance requirements.
Experience in software development lifecycle activities, including:
Requirements gathering
Technical specification development
Coding
Testing and validation
Experience working with globally distributed teams and cross-cultural stakeholders.
Strong written and verbal English communication skills.
Preferred Qualifications
Master's degree or higher in Statistics, Biostatistics, Mathematics, or a related field.
Experience with open-source programming languages and tools such as:
R
Python
Familiarity with automation platforms and emerging technologies in statistical programming.
Experience driving digital transformation and innovation initiatives within programming functions.
Key Skills
Statistical Programming
SAS Programming
Clinical Trial Data Analysis
Regulatory Submission Support
Team Leadership
Project Management
Data Quality & Compliance
Process Improvement
Resource Planning
Mentoring & Staff Development
Cross-Functional Collaboration
R and Python (Preferred)
Experience Required
8+ years of statistical programming experience in clinical research, pharmaceutical, biotechnology, or CRO environments.
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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Remote, India | Siliguri |Illinois :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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