Statistical Analyst / Statistical Programmer
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Job Summary
The Statistical Analyst / Statistical Programmer is responsible for supporting clinical research and drug development programs through statistical programming, data analysis, and reporting activities. The role involves developing and validating ADaM datasets, generating Tables, Listings, and Figures (TLFs), supporting statistical analyses, and ensuring compliance with CDISC standards and regulatory requirements.
Key Responsibilities
Statistical Programming
Program and validate ADaM datasets using SAS and/or R programming languages.
Implement Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs) for clinical studies.
Develop statistical programming solutions in compliance with CDISC and regulatory standards.
Create reusable programming macros and automate reporting processes where appropriate.
Clinical Data Analysis & Reporting
Generate Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, safety reports, and other study deliverables.
Perform statistical analyses according to approved protocols and SAPs.
Support data review and interpretation activities in collaboration with statisticians and study teams.
Ensure accuracy, consistency, and quality of all statistical outputs.
Data Standards & Compliance
Apply CDISC standards, including ADaM and SDTM requirements, across programming deliverables.
Ensure compliance with regulatory guidelines, company standards, and industry best practices.
Maintain detailed programming documentation, validation records, and audit-ready files.
Support regulatory submissions and inspection readiness activities.
Quality Control & Validation
Perform independent validation and quality control of statistical programming deliverables.
Review datasets, TLFs, and analysis outputs for completeness and accuracy.
Identify and resolve programming issues, discrepancies, and data inconsistencies.
Maintain high standards of quality and documentation throughout the project lifecycle.
Cross-Functional Collaboration
Collaborate closely with statisticians, data management teams, clinical scientists, and external partners.
Participate in protocol reviews, SAP reviews, and study planning discussions.
Provide programming support throughout the clinical study lifecycle.
Communicate project status, risks, and deliverables effectively to stakeholders.
Required Qualifications
Education
Bachelor’s Degree in Computer Science, Pharmacy, Statistics, Life Sciences, Mathematics, Biotechnology, or a related discipline.
Master of Pharmacy (M.Pharm), Statistics, Biostatistics, or related advanced degree preferred.
Experience
2–4 years of experience in Statistical Programming, Clinical Data Analysis, or Biostatistics.
Experience within pharmaceutical, biotechnology, CRO, or clinical research environments preferred.
Hands-on experience supporting clinical trials and regulatory submissions.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Amsterdam |North Brabant :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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