Principal Biostatistician
Location: Bangalore
Category: Clinical
Job ID: 254114
Summary of Responsibilities
(Not exhaustive; may include other duties as assigned)
Lead complex studies such as NDA submissions or multi-protocol programs, coordinating activities across multiple locations, providing statistical oversight, and attending project meetings.
Manage projects: resource planning, timelines, and milestone tracking.
Serve as DMC Support Statistician by developing DMC Charters and attending DMC meetings under Statistical Consultant direction.
Lead the development of complex Statistical Analysis Plans (SAPs) and provide senior review of SAPs prepared by other statisticians.
Perform complex statistical analyses and quality check analyses produced by other statisticians.
Conduct overall statistical review of TFLs (Tables, Figures, Listings) for complex studies prior to client delivery.
Review CRFs and other study-specific specifications and plans.
Perform complex sample size calculations under senior statistical staff supervision.
Develop statistical sections of protocols for complex studies under Statistical Consultant supervision.
Provide statistical input and review for Clinical Study Reports (CSRs).
Prepare and review randomization specifications; generate randomization schedules.
Mentor and train junior staff, providing oversight, direction, and review to ensure accuracy and compliance.
Present and share knowledge internally (seminars, team meetings) and externally (scientific meetings, conferences).
Participate in bid defense meetings for complex studies (e.g., NDA submissions) to support new business opportunities.
Act as Subject Matter Expert (SME) in developing/reviewing procedural documents or leading new initiatives.
Represent the department during audits.
Qualifications (Minimum Required)
Bachelor’s degree in a relevant field.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
8+ years’ experience, or an equivalent combination of education and experience, to successfully perform key responsibilities.
Proficiency in SAS® programming and statistical procedures (e.g., non-parametric analysis, linear and non-linear models, categorical data, survival analysis).
Strong ability to communicate statistical concepts effectively.
Solid understanding of the clinical trial process and its application in Fortrea Clinical Development.
Proven competence in preparation of SAPs, statistical analyses, and reporting across diverse trials.
Preferred Qualifications
Master’s degree or higher in Biostatistics or a related field.
Work Environment / Physical Demands
Office or home-based environment, as directed by the line manager.
Travel requirements:
Approximately 5% of time.
Of this, up to 100% may require overnight stays.
Travel primarily for client meetings and trainings.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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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) :
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Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Frankfurt | Harveysburg |Germany :
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 :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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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 | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
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 :
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