R Statistical Programmer – Submission Experience Required
Location: India (Remote) / UK / Armenia / South Africa (Flexible Hiring Regions)
Work Mode: Remote
Department: Statistical Programming / Clinical Data Science
Job Overview
We are seeking an experienced R Statistical Programmer with strong clinical trial submission experience to support global regulatory submissions and clinical development programs. This role involves developing statistical programming solutions using R and other programming tools, generating submission-ready outputs, and ensuring compliance with regulatory and CDISC standards.
The position requires hands-on expertise in ADaM programming, clinical trial submissions, SDTM/ADaM datasets, and regulatory deliverables, along with strong leadership and cross-functional collaboration skills.
Key Responsibilities
Statistical Programming (R-Based Development)
Develop and maintain custom programming solutions using R and other statistical tools.
Generate:
Summary Tables
Data Listings
Graphs and Figures
Derived Analysis Datasets
Ensure all outputs align with Statistical Analysis Plans (SAPs) and programming specifications.
Ensure accuracy, consistency, and regulatory compliance of all deliverables.
Clinical Trial Submission Support
Support regulatory submissions with submission-ready datasets and outputs.
Ensure compliance with global submission requirements and industry standards.
Contribute to CDISC-compliant deliverables, including SDTM and ADaM datasets.
Perform compliance reviews for submission artifacts including DEFINE.XML and related documentation.
ADaM and SDTM Programming
Develop and validate ADaM datasets in compliance with CDISC standards.
Work with SDTM datasets for analysis and submission requirements.
Ensure consistency between SAP, datasets, and final outputs.
Support integrated understanding of analysis datasets for regulatory filings.
Validation and Quality Assurance
Perform independent validation programming and QC of outputs.
Identify and resolve discrepancies in datasets and statistical outputs.
Ensure inspection-ready documentation and validation records are maintained.
Follow SOPs, Work Instructions (WIs), and regulatory guidelines (e.g., ICH).
Project Execution and Delivery Management
Manage multiple programming deliverables across concurrent studies.
Ensure on-time delivery of all statistical programming outputs.
Develop risk mitigation plans for project delays or issues.
Communicate progress, risks, and issues proactively to management.
Study and Program Leadership
Act as lead statistical programmer on assigned studies or submissions.
Direct programming activities of junior programmers and monitor deliverables.
Review key study documents including:
SAPs (Statistical Analysis Plans)
Mock TLF shells
Programming specifications
Annotated CRFs
Database design documents
Provide feedback to improve programming efficiency and reduce rework.
Stakeholder Collaboration
Participate in sponsor meetings, kickoff meetings, and bid defenses.
Serve as statistical programming representative in client discussions.
Collaborate with biostatisticians, data managers, and regulatory teams.
Communicate effectively across global, cross-functional teams.
Mentorship and Training
Mentor junior statistical programmers and support capability development.
Develop training materials and conduct technical knowledge-sharing sessions.
Guide teams on CDISC standards and submission best practices.
Promote standardization and efficiency across programming processes.
Standards, Tools, and Innovation
Contribute to development of SOPs, programming standards, and guidelines.
Support creation of reusable macros and programming tools.
Provide expertise in CDISC standards (SDTM, ADaM).
Ensure compliance with regulatory and industry requirements.
Required Qualifications
Education
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, Pharmacy, or a related field.
Experience Required
Fresher Eligible: No
Required Experience: Minimum 5–8+ years of experience in Clinical Statistical Programming
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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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Frankfurt | Harveysburg |Germany :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Witney |Ontario :
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Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
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Athens | Koropi |Greece :
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Auckland |New Zealand :
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Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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King Abdullah Economic City | Jeddah | Rabigh | Najran | Khulais | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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