Senior Statistical Programmer
Location: India (Remote)
Work Mode: Remote
Department: Statistical Programming / Clinical Data Science
Job Overview
We are seeking an experienced Senior Statistical Programmer to support clinical trial programming activities across global drug development programs. This role is responsible for generating high-quality statistical outputs, developing analysis datasets, ensuring compliance with regulatory standards, and supporting end-to-end clinical reporting needs.
The position requires strong expertise in SAS programming, SDTM/ADaM datasets, TLF development, and clinical analysis support, along with proven leadership in managing study deliverables and cross-functional collaboration.
Key Responsibilities
Statistical Programming and Development
Develop SAS programs to generate:
Summary Tables
Data Listings
Graphs and Figures
Derived Analysis Datasets
Translate Statistical Analysis Plans (SAPs) and programming specifications into validated outputs.
Ensure programming deliverables meet study requirements, sponsor expectations, and quality standards.
ADaM, SDTM and Clinical Data Outputs
Support development and validation of ADaM datasets aligned with CDISC standards.
Work with SDTM datasets for analysis and reporting needs.
Develop and validate Tables, Listings, and Figures (TLFs) for clinical studies.
Ensure consistency between analysis datasets, SAPs, and final outputs.
Validation and Quality Control
Perform validation programming and independent quality checks.
Identify and resolve discrepancies in datasets and outputs.
Maintain inspection-ready documentation, test scripts, and QC records.
Ensure adherence to SOPs, Work Instructions (WIs), and regulatory guidelines (e.g., ICH).
Study Execution and Project Management
Manage multiple studies and programming deliverables simultaneously.
Adapt to changing priorities, timelines, and project requirements.
Develop dataset and output specifications as per sponsor requirements.
Ensure accurate definition of variables and minimize rework through proactive planning.
Collaboration and Communication
Collaborate with statisticians, data managers, and cross-functional teams.
Provide regular updates on programming progress, risks, and issues.
Participate in internal meetings, ensuring effective communication and documentation.
Prepare and distribute meeting notes and track action items to closure.
Technical Leadership
Act as lead statistical programmer on assigned studies.
Direct programming activities of junior and peer programmers.
Review key study documents including:
SAPs (Statistical Analysis Plans)
Mock TLF shells
Programming specifications
Annotated CRFs
SAS database design documents
Provide constructive feedback to improve programming efficiency and quality.
Client and Sponsor Engagement
Participate in sponsor meetings, study kick-off meetings, and bid defense discussions.
Represent statistical programming function in client-facing interactions.
Ensure deliverables align with sponsor expectations and timelines.
Mentoring and Training
Mentor junior programmers and support capability development.
Develop and deliver training materials and technical guidance.
Promote best practices in statistical programming and CDISC implementation.
Required Qualifications
Education
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, Pharmacy, or related field.
Experience Required
Fresher Eligible: No
Required Experience: Minimum 5–8+ years of experience in Clinical SAS Programming.
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 :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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 :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Budapest |BULGARIA :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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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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Japan | Saitama |Tokyo :
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Bangkok |Israel :
Yavne | Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya |Remote :
McFarland | Faridabad | Perth | Xzagreb | Remote - South America (Latin Americal) | Springville | Remote - Africa | Bountiful | Manipal | Nairobi | Hungary | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Remote - Europe | Leinster | Minnesota | Belgium | Hammond | Riga | Zaragoza | Slovakia | Blue Bell | French | Tulsa | Texas | Lousiana | Medan | Ireland | Lenexa | Castlebar | Switzerland | Victoria | Melbourne | Thailand | Milwaukee | Bishop | Green Way |Republic of Colombia :
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King Abdullah Economic City | Jeddah | Rabigh | Najran | Khulais | Riyadh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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