Job Title
Senior Manager – Biostatistics
Company
Sun Pharmaceutical Industries Ltd
Business Unit
Global Clinical Development
Location
Gurgaon (R&D) / Remote / Hybrid
Job Grade
Manager
Job Overview
The Senior Manager – Biostatistics will act as the study biostatistician for global clinical development programs, supporting the design, execution, analysis, and interpretation of clinical trials and regulatory submissions. The role involves leadership of statistical deliverables across multiple studies and collaboration with cross-functional global teams to ensure high-quality, compliant, and timely outputs.
Key Responsibilities
1. Study Leadership & Statistical Strategy
Serve as lead biostatistician for clinical development programs and multiple studies
Define and execute statistical strategies for assigned studies
Provide statistical input to clinical development plans and study designs
Participate in cross-functional and project team meetings
2. Statistical Documents & Study Deliverables
Author Statistical Analysis Plans (SAPs), TFL shells, and other statistical documentation
Review ADaM specifications and oversee generation of ADaM datasets and TLFs
Ensure timely and high-quality statistical deliverables for studies and submissions
Provide statistical input to Clinical Study Reports (CSRs)
3. Statistical Analysis & Methodology
Plan and execute primary, secondary, and exploratory statistical analyses
Conduct advanced statistical consultations within cross-functional teams
Support simulation studies for trial design optimization
Contribute to innovative statistical methodologies and trial design improvements
4. Regulatory & Submission Support
Provide statistical support for regulatory submissions (NDA/BLA, eCTD)
Respond to Health Authority queries and requests
Support publications, posters, and scientific presentations
5. Process Improvement & Standards
Participate in SOP development and process improvement initiatives
Contribute to standardization of statistical processes and tools
Support training and development of statistical practices within the team
6. Collaboration & Stakeholder Management
Work closely with clinical, regulatory, programming, and data science teams
Ensure clear communication of statistical concepts and decisions
Promote teamwork, accountability, and high-performance culture
7. Compliance & Quality Assurance
Ensure adherence to GxP, regulatory guidelines, and company SOPs
Maintain high standards of quality, accuracy, and documentation
Ensure compliance across all statistical deliverables
Required Qualifications
PhD in Statistics/Biostatistics with 5+ years of experience
OR
Master’s degree with 10+ years of experience in pharma R&D
Strong understanding of Phase I–IV clinical development
Expertise in statistical methodologies and clinical interpretation
Proficiency in SAS and R programming
Experience with NDA/BLA submissions and eCTD preferred
Experience in oncology or dermatology preferred
Strong leadership and cross-functional collaboration skills
Excellent communication and stakeholder management abilities
Strong analytical thinking and problem-solving skills
Ability to manage multiple complex projects independently
Educational Qualification
PhD or Master’s in Statistics / Biostatistics
Experience Required
PhD: 5+ years industry experience
Master’s: 10+ years industry experience
Uttar Pradesh :
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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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
Richmond Hill | Renfrew | Uxbridge | Mississauga | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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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 :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
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Kfar Saba | Netanya | Yavne | Tel Aviv | Be'Er Sheva |Remote :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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