Senior / Principal Biostatistician – Immunology & Inflammation (Europe & LATAM)
Updated: Yesterday
Location: Pune, Maharashtra, India
Regions Supported: Europe and Latin America only
Job ID: 25105208-OTHLOC-5580-2DR
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating the delivery of innovative therapies worldwide. By combining expertise across clinical development, medical affairs, and commercial operations, Syneos Health supports sponsors in navigating complex global development programs. With a workforce of more than 29,000 professionals across 110 countries, Syneos Health plays a critical role in advancing patient-centric clinical research.
Position Overview
The Senior / Principal Biostatistician – Immunology & Inflammation provides strategic and operational biostatistics leadership across late-phase clinical development programs, primarily supporting Europe and Latin America (LATAM) regions. This role involves end-to-end statistical oversight from protocol development through clinical study reporting, with a focus on Phase II–III trials in immunology and inflammation therapeutic areas.
This position is open only to candidates eligible to work in Europe or LATAM without sponsorship requirements.
Required Experience
Senior Biostatistician: Minimum 6–8 years of clinical trial biostatistics experience
Principal Biostatistician: Minimum 9–12 years of clinical trial biostatistics experience
Proven experience in Immunology and/or Inflammation therapeutic areas
Demonstrated leadership on Phase II–III clinical trials, including study-level statistical ownership
Strong working knowledge of EU and LATAM regulatory expectations
Hands-on experience with SAS and/or R
Key Responsibilities
Study Leadership and Statistical Oversight
Act as study lead biostatistician for one to two late-phase clinical protocols (Phase II–III)
Support Phase III studies in collaboration with a lead statistician, as required
Contribute to study risk management planning, including development of Study Risk Management Plans (SRMPs)
Oversee Interactive Response Technology (IRT), eCRF design, and Data Monitoring Committee (DMC) setup
Statistical Planning and Analysis
Prepare and review Statistical Analysis Plans (SAPs), tables, listings, and figures (TLFs), and statistical methods sections
Lead or support Statistical Surveillance (STS) activities, including blinded data review, statistical assumptions assessment, intercurrent event handling, and ongoing data quality evaluation
Participate in STS meetings throughout the study lifecycle to assess recruitment trends, data integrity, and protocol compliance
Programming and Data Review
Review and approve programming specifications for analysis datasets, TLFs, and derived variables
Perform or support partial statistical programming for efficacy analyses using SAS or R
Review annotated CRFs, database designs, and ensure alignment with protocol and analysis requirements
Quality, Compliance, and Collaboration
Conduct quality control and verification of statistical deliverables to ensure compliance with SAPs, specifications, and regulatory guidelines
Serve as the biostatistics representative on cross-functional project teams, collaborating with clinical, data management, and programming colleagues
Maintain inspection-ready documentation in accordance with SOPs, work instructions, and ICH guidelines
Leadership and Business Support
Coordinate and review work produced by other biostatisticians and statistical programmers, ensuring timely and high-quality outputs
Mentor and coach junior biostatistics staff
Support business development activities, including proposal development, budget input, and participation in sponsor bid defense meetings
Contribute to integrated analyses and regulatory interactions, including responses to agency questions when required
Qualifications and Skills
Master’s or PhD degree in Biostatistics, Statistics, Mathematics, or a related discipline
Strong expertise in late-phase clinical trial design and analysis
Proficiency in SAS and/or R for clinical trial analysis
In-depth knowledge of ICH guidelines and global regulatory expectations
Excellent analytical, problem-solving, and communication skills
Ability to manage multiple studies simultaneously while meeting strict timelines
Strong leadership, mentoring, and stakeholder management capabilities
Why Join Syneos Health
Work on global Phase II–III clinical trials in immunology and inflammation
Exposure to Europe and LATAM regulatory environments
Collaborative, inclusive culture with strong emphasis on professional development
Opportunities to influence study design, regulatory strategy, and integrated analyses
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000+ sites and more than 675,000 trial participants worldwide
Additional Information
The responsibilities listed are not exhaustive and may evolve based on business requirements. Equivalent experience and education may be considered. Syneos Health is an equal opportunity employer and complies with all applicable employment and accessibility regulations.
Job Summary
The Senior / Principal Biostatistician provides strategic statistical leadership and hands-on expertise across late-phase clinical development programs in immunology and inflammation. This role supports protocol development, statistical analysis, regulatory interactions, and cross-functional collaboration to ensure high-quality, compliant, and timely delivery of clinical trial results for Europe and LATAM markets.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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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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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 | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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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 :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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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 :
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Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Netanya | Kfar Saba | Yavne | Tel Aviv |Remote :
Lenexa | Regulatory Labeling Manager (NA and LATAM Only) | Blue Bell | Thailand | Victoria | Lousiana | Bountiful | Zaragoza | Remote - Africa | Remote, USA | Slovakia | Texas | Minnesota | Hungary | Hammond | Remote | Remote - Europe | Remote - Middle East | Remote - South America (Latin Americal) | Faridabad | Tulsa | Ireland | Medan | Riga | Belgium | Melbourne | McFarland | Bishop | Castlebar | French | Green Way | Leinster | Nairobi | Switzerland | Springville | Manipal | Xzagreb |Republic of Colombia :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | King Abdullah Economic City | Riyadh | Najran | Jeddah | Khulais |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 :
Sofia |Sweden :
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