Principal Biostatistician
Location: Hyderabad, India
Work Mode: Hybrid
Department: Biostatistics / Clinical Solutions
Job Overview
We are seeking an experienced Principal Biostatistician to provide advanced statistical leadership and expertise across clinical development programs. This role is responsible for supporting all phases of clinical trials from protocol development through clinical study report (CSR), ensuring high-quality statistical deliverables, regulatory compliance, and scientific integrity.
The Principal Biostatistician will act as a senior statistical expert, leading study-level and program-level activities, mentoring biostatistics staff, supporting submissions and integrated analyses, and collaborating with cross-functional clinical, regulatory, and programming teams.
Key Responsibilities
Statistical Leadership and Team Development
Serve as a statistical department resource and subject matter expert.
Mentor and train biostatisticians, supporting skill development and career growth.
Develop and deliver training programs and technical guidance for biostatistics staff.
Provide independent review of statistical work across projects and studies.
Support onboarding and capability building for new hires.
Study Design and Statistical Planning
Provide end-to-end statistical support across the clinical trial lifecycle (Protocol to CSR).
Prepare or oversee Statistical Analysis Plans (SAPs).
Develop mock shells for Tables, Listings, and Figures (TLFs).
Contribute to study protocols and statistical design strategies.
May serve as Lead Biostatistician for protocol-level statistical planning and CSR input.
Support generation or review of randomization schedules.
Clinical Trial Execution and Analysis Support
Provide statistical oversight for multiple concurrent studies.
Ensure alignment of analysis datasets, TLFs, and outputs with SAPs and specifications.
Review programming specifications for accuracy and completeness.
Ensure high-quality statistical deliverables throughout study execution.
Data Review and Quality Assurance
Review annotated CRFs, database structures, and study documentation.
Ensure all data collection aligns with protocol and analysis requirements.
Conduct quality control and verification of statistical outputs.
Maintain inspection-ready documentation and ensure compliance with standards.
Cross-Functional Collaboration
Act as biostatistics representative on global project teams.
Collaborate with clinical operations, programming, data management, and regulatory teams.
Contribute to internal and sponsor meetings with statistical insights.
Support alignment of statistical strategies with study objectives.
Project and Timeline Management
Manage multiple studies and deliverables simultaneously.
Monitor project milestones and ensure timely execution of statistical tasks.
Communicate proactively regarding risks, delays, or resource constraints.
Escalate out-of-scope activities and support mitigation planning.
Coordinate priorities with management to ensure efficient workload distribution.
Regulatory and Compliance Support
Ensure adherence to applicable SOPs, Work Instructions (WIs), and regulatory guidelines (e.g., ICH).
Support inspection readiness through complete and organized documentation.
Participate in regulatory discussions and responses when required.
Contribute to submission-ready statistical documentation.
DSMB / DMC and Advanced Statistical Activities
Participate in Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities.
Support charter development and statistical oversight responsibilities.
Serve as non-voting or voting statistician where applicable.
Business Development Support
Contribute to proposals, study budgets, and bid defense meetings.
Provide statistical input during project feasibility and planning discussions.
Support solution development for new clinical opportunities.
Process Improvement and Knowledge Sharing
Share best practices and promote statistical excellence across teams.
Contribute to continuous improvement initiatives.
Support innovation in statistical methodologies and clinical analytics.
Required Qualifications
Education
Master’s Degree or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
Experience
Extensive experience in biostatistics within clinical research, pharmaceutical, biotechnology, or CRO environments.
Prior experience in lead or principal biostatistician roles is required.
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, 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 :
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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 :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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 :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
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 :
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 :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |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 :
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 :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba |Remote :
Melbourne | Medan | Thailand | Belgium | French | Perth | Remote - Africa | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Remote - Middle East | Blue Bell | Manipal | Leinster | Springville | Tulsa | Hungary | Zaragoza | Ireland | Texas | Riga | Victoria | Castlebar | Lousiana | Xzagreb | Milwaukee | Faridabad | McFarland | Switzerland | Bountiful | Slovakia | Lenexa | Remote - South America (Latin Americal) | Hammond | Green Way | Bishop | Remote - Europe |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Najran | Khulais | Rabigh | Riyadh | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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