Senior Statistical Programmer (ADaM, TLF & SDTM)
Location: Remote – India
Work Mode: Remote
Department: Biostatistics & Statistical Programming
Job Overview
We are seeking an experienced Senior Statistical Programmer to support clinical research and drug development programs through advanced statistical programming, clinical data analysis, and regulatory-compliant deliverables. This role involves developing analysis datasets, generating statistical outputs, ensuring data quality, and collaborating with cross-functional teams throughout the clinical trial lifecycle.
The ideal candidate should possess strong expertise in Base SAS, SAS Macros, ADaM, SDTM, and TLF programming, along with a solid understanding of clinical trial processes, CDISC standards, and regulatory requirements.
Key Responsibilities
Statistical Programming
Develop custom SAS programs to generate:
Summary Tables
Data Listings
Figures and Graphs
Analysis Datasets
Create and validate statistical outputs according to Statistical Analysis Plans (SAPs) and programming specifications.
Develop complex programming solutions to support clinical trial analyses and reporting requirements.
Ensure all programming deliverables meet quality standards and project timelines.
ADaM, SDTM and TLF Development
Create and maintain ADaM datasets in compliance with CDISC standards.
Review and utilize SDTM datasets for statistical analysis and reporting.
Generate TLFs (Tables, Listings, and Figures) for clinical study reports and regulatory submissions.
Develop programming specifications and dataset structures according to sponsor and regulatory requirements.
Quality Control and Validation
Perform validation programming and independent quality checks.
Identify, investigate, and resolve programming discrepancies.
Maintain inspection-ready documentation, validation records, and quality control evidence.
Ensure compliance with SOPs, Work Instructions (WIs), and regulatory guidelines.
Project and Study Management
Manage programming activities across multiple studies and projects simultaneously.
Monitor project timelines and ensure timely delivery of programming deliverables.
Anticipate programming challenges and implement effective solutions.
Adapt to changing project priorities and deadlines while maintaining quality standards.
Leadership and Team Collaboration
Act as the lead statistical programmer on assigned studies.
Guide and oversee programming activities performed by other statistical programmers.
Review key study documentation, including:
Statistical Analysis Plans (SAPs)
Mock Shells
Programming Specifications
Annotated CRFs
Database Design Documents
Provide technical feedback to improve programming efficiency and data quality.
Stakeholder Engagement
Participate in sponsor meetings, project kickoff meetings, and bid defense meetings.
Collaborate with biostatisticians, data managers, clinical teams, and project stakeholders.
Communicate project status, risks, and deliverables effectively.
Training and Mentorship
Mentor junior statistical programmers and new team members.
Support training initiatives and knowledge-sharing activities.
Review programming work and provide constructive feedback.
Contribute to process improvements and best practices within the statistical programming function.
Required Qualifications
Education
Bachelor's Degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, Pharmacy, or a related field.
Master's Degree preferred.
Experience
Minimum 5+ years of experience in Clinical SAS Programming within the pharmaceutical, biotechnology, CRO, or clinical research industry.
Uttar Pradesh :
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