Senior Biostatistician I / II
Job Title: Senior Biostatistician I / II
Location: Bangalore, Chennai, or Trivandrum, India
Work Model: Office or Home (Hybrid/Remote Eligible)
Employment Type: Full-Time
Job Requisition ID: JR151271
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and therapies that improve patient outcomes worldwide.
Driven by its core values of Integrity, Collaboration, Agility, and Inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to support clinical development, regulatory submissions, and market access for life-changing treatments.
Position Overview
ICON is seeking an experienced Senior Biostatistician I / II to join its Biometrics team. In this role, you will provide statistical leadership for clinical development programs, oversee the design and analysis of clinical studies, and support regulatory submissions.
As a lead biostatistician, you will collaborate closely with clinical, statistical programming, regulatory, and client teams to ensure scientifically sound study designs, high-quality analyses, and successful delivery of clinical research projects.
This position offers opportunities to contribute strategically to drug development programs while mentoring junior statisticians and supporting business development initiatives.
Key Responsibilities
Statistical Leadership
Serve as the Lead Biostatistician for:
Individual clinical studies
Multi-study programs
Regulatory submissions
Clinical development projects
Provide strategic statistical guidance throughout the clinical trial lifecycle.
Ensure statistical methodologies align with scientific and regulatory requirements.
Clinical Trial Design & Analysis
Design and oversee statistical analyses for Phase I–IV clinical studies.
Develop and review:
Study protocols
Statistical Analysis Plans (SAPs)
Randomization methodologies
Sample size calculations
Statistical reports
Interpret complex clinical and medical data to support decision-making.
Regulatory Support
Support regulatory submissions and agency interactions.
Contribute statistical expertise for:
NDA (New Drug Application) submissions
Regulatory responses
Health authority requests
Clinical study reports
Ensure compliance with global regulatory standards and statistical best practices.
Statistical Programming
Utilize SAS and/or R programming for:
Statistical analyses
Data review
Inferential statistics
Reporting outputs
Collaborate with statistical programmers to ensure accurate implementation of analysis plans.
Client & Business Development Support
Participate in client meetings and scientific discussions.
Support proposal development and budget preparation for statistical consulting projects.
Contribute to bid defense meetings and presentations with prospective clients.
Provide expert statistical consultation throughout project planning and execution.
Team Leadership & Mentorship
Mentor and support junior statisticians and team members.
Provide technical guidance on statistical methodologies and regulatory expectations.
Promote knowledge sharing and professional development within the team.
Process Improvement
Lead or contribute to initiatives focused on:
Statistical process optimization
Methodology improvements
Development of internal guidance documents
Quality enhancement initiatives
Support innovation and continuous improvement within the Biometrics function.
Required Qualifications
Education
Required
Master's Degree in:
Biostatistics
Statistics
Mathematics
Related Quantitative Discipline
Preferred
Ph.D. in:
Biostatistics
Statistics
Related Scientific Field
Required Experience
Minimum 6+ years of biostatistics experience within:
Clinical Research Organizations (CROs)
Pharmaceutical companies
Biotechnology companies
Proven experience supporting clinical development programs and statistical analyses.
Preferred
Prior experience within a Clinical Research Organization (CRO).
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 :
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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 :
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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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
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 :
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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 :
Mississauga | Australia | Renfrew | Richmond Hill | Uxbridge | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |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 :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Yavne | Tel Aviv | Netanya |Remote :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Rabigh | Khulais | Riyadh | Najran | King Abdullah Economic City | 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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Sweden |Taipei :
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Warsaw |
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