Senior Statistical Programmer I (SDTM Programming & Oversight)
Location: India (Bangalore) | South Africa (Middelburg) | Mexico (Mexico City) | Ireland (Limerick, Dublin) | Remote/Hybrid (Office or Home)
Job Type: Full-Time
Company: ICON plc
Job ID: JR146091
Application Deadline: March 27, 2026
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Senior Statistical Programmer I with a strong focus on SDTM programming and oversight activities. This role plays a critical part in clinical trial data analysis, regulatory submissions, and ensuring high-quality, compliant statistical outputs.
You will work closely with biostatisticians and cross-functional teams to develop, validate, and maintain statistical programs that support global clinical studies.
Key Responsibilities
Develop, validate, and maintain SDTM datasets in compliance with CDISC standards
Translate study protocols into detailed technical specifications and mapping documentation (including aCRF and data transfer agreements)
Create and maintain Data Review Models (DRM) based on current standards
Develop backend edit checks, listings, and visualizations for risk-based monitoring (QTLs, CtQ)
Perform quality control (QC) of all clinical programming deliverables
Support data cleaning, unblinding, data cuts, and database lock activities
Contribute to the development of electronic submission packages (FDA, EMA, and other regulatory authorities)
Review and provide input into study setup documentation
Ensure adherence to SOPs, WIs, and regulatory guidelines
Support the development and implementation of programming standards across the organization
Required Qualifications & Experience
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or a related field
Minimum 4+ years of experience in statistical programming within clinical research or the pharmaceutical industry
Strong expertise in SAS programming and SDTM dataset development
Solid understanding of CDISC standards and clinical trial data structures
Experience with regulatory submissions (FDA, EMA)
Strong analytical, problem-solving, and data validation skills
Excellent attention to detail and ability to manage multiple deliverables
Strong communication and collaboration skills in global team environments
Preferred Skills
Experience in risk-based monitoring and central data review
Exposure to advanced data visualization and reporting techniques
Experience contributing to organizational standards and process improvements
Why Join ICON
ICON offers a collaborative, innovation-driven environment with opportunities to work on global clinical trials and cutting-edge research programs.
Key Benefits Include
Competitive salary and global career exposure
Flexible work arrangements (remote/hybrid options)
Generous leave policies
Comprehensive health insurance
Retirement and financial planning benefits
Employee Assistance Programme (24/7 support)
Life insurance and wellness programs
Flexible, country-specific employee benefits
Diversity, Equity & Inclusion
ICON is committed to fostering an inclusive workplace. All qualified applicants will receive equal consideration regardless of background or protected characteristics.
Application Note
Candidates who may not meet every requirement are encouraged to apply. ICON values diverse experiences and supports continuous professional development.
This opportunity is ideal for experienced statistical programmers looking to advance their expertise in SDTM programming, regulatory submissions, and global clinical data analysis within a leading CRO environment.
Uttar Pradesh :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Seoul |Kazakhstan :
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Bangkok |Israel :
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Niš |Bohemia :
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