Principal Statistical Programmer (ADaM & TLF)
Location: India (Remote)
Work Mode: Remote
Department: Statistical Programming / Biostatistics
Job Overview
We are seeking an experienced Principal Statistical Programmer with strong expertise in ADaM and TLF programming to lead statistical programming activities across clinical research studies. This role is responsible for developing high-quality statistical programs, ensuring data integrity, defining programming standards, and providing technical leadership across multiple clinical trials and submissions.
The role requires deep expertise in Clinical SAS programming, CDISC standards, and end-to-end clinical data analysis support, along with proven leadership in managing studies and client interactions.
Key Responsibilities
Statistical Programming Leadership
Develop, implement, and maintain statistical programming standards and best practices.
Provide technical leadership in the design and development of complex statistical programs.
Design efficient and scalable programming solutions to meet study requirements.
Ensure consistency, accuracy, and reproducibility of statistical outputs.
ADaM and TLF Development
Lead development of ADaM datasets in compliance with CDISC standards.
Create and validate Tables, Listings, and Figures (TLFs) for clinical study reporting.
Develop ADaM specifications and dataset generation strategies.
Support integrated analysis activities including ISS/ISE and pooled datasets.
Ensure alignment between ADaM datasets, SAPs, and statistical outputs.
Clinical Programming and Data Integrity
Ensure accuracy and integrity of clinical trial data and statistical outputs.
Troubleshoot and resolve complex programming issues across studies.
Conduct thorough validation and quality checks of deliverables.
Maintain compliance with SOPs, programming standards, and regulatory requirements.
Collaboration and Stakeholder Management
Collaborate closely with statisticians, data managers, and clinical stakeholders.
Act as a key programming representative in study and project discussions.
Provide clear communication of programming status, risks, and deliverables.
Support client communication and handle study-level programming discussions.
Study Leadership and Oversight
Lead statistical programming activities for one or more clinical studies.
Coordinate deliverables across multiple concurrent projects.
Ensure timely execution of programming tasks and adherence to timelines.
Manage study priorities and resolve operational challenges effectively.
Mentoring and Team Development
Mentor and train junior statistical programmers.
Conduct code reviews and provide constructive feedback.
Support knowledge sharing and capability development within the team.
Contribute to continuous improvement of programming workflows and tools.
Process Improvement and Innovation
Contribute to enhancements in statistical programming processes and standards.
Stay updated with advancements in SAS programming and clinical analytics.
Incorporate new techniques and tools to improve efficiency and quality.
Support automation and optimization initiatives in programming workflows.
Required Qualifications
Education
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, Pharmacy, or a related field.
Experience
Minimum 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 :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
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 :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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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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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
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 :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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Warsaw |
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