Job Title: Principal Statistical Programmer – Sponsor Dedicated
Location: 21 Locations (100% home-based in EMEA or local office in home country)
Category: Clinical
Job ID: 253606
The Principal Statistical Programmer plays a critical role in delivering complex clinical projects for a leading global pharmaceutical sponsor. This role involves planning, executing, and overseeing programming activities, liaising with cross-functional teams, mentoring junior programmers, supporting submissions, and ensuring high-quality outputs aligned with regulatory and sponsor standards.
Programming Oversight
Plan, execute, and oversee all statistical programming activities for assigned studies.
Manage resources, work within budget, meet timelines, and maximize quality.
Oversee SDTM, ADaM, and TLF development and perform senior-level review of outputs.
Cross-Functional Collaboration
Liaise with Clinical, Medical Writing, Safety, and Biometrics teams.
Coordinate additional programming support for publications, medical writing, and analyses.
Support and oversee submission activities, particularly in late-phase studies.
Quality & Process Management
Ensure efficient execution of programming tasks with proper tools and macros.
Prioritize quality while adhering to departmental standards and processes.
Mentorship & Training
Mentor less-experienced team members on SDTM, ADaM, and TFL best practices.
Promote adherence to programming standards and departmental processes.
Degree in Mathematics, Life Sciences, Statistics, Computer Science, or equivalent professional experience in statistical programming within clinical trials.
Minimum 5 years of experience with complex clinical trials, including understanding of safety and efficacy datasets and endpoints.
Knowledge of end-to-end clinical trial processes, including roles of Biostatistics and Clinical Data Management.
Expert knowledge of base SAS, SAS macros, SAS/STAT, and debugging SAS programs.
Broad understanding of CDISC standards (SDTM, ADaM), define.xml, Reviewer's Guides, and submission requirements.
Fluency in English, both verbal and written.
Autonomous, collaborative, detail-oriented, and curious mindset.
Experience supporting regulatory submissions and publications.
Exposure to multi-therapeutic area studies.
Leadership experience in guiding junior programmers and cross-functional teams.
Home-based or office-based in EMEA.
Collaborative global CRO environment with opportunities for career growth.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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 | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Netherlands |Remote Australia :
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Harrogate |South Yorkshire :
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Heist op den Berg |Flemish Brabant :
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Argentina | Peru |Brazil :
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Zagreb |Estonia :
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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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
Bishop | Melbourne | Switzerland | Nairobi | Slovakia | Lenexa | Xzagreb | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Green Way | Remote, USA | Texas | Ireland | Springville | Hammond | Remote - South America (Latin Americal) | Zaragoza | Minnesota | Remote | Medan | French | Tulsa | Hungary | Faridabad | Remote - Middle East | Victoria | Lousiana | Thailand | Remote - Africa | Manipal | Castlebar | Riga | Leinster | Belgium | Bountiful | McFarland |Republic of Colombia :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |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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Singapore |Sofia City :
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