Senior Principal Biostatistician
REQ-10056839
Hyderabad, India
Hyderabad (Office)
Development
Innovative Medicines
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Research & Development
Full-time | Regular
No
August 26, 2025
The Senior Principal Biostatistician is responsible for statistical leadership at the trial, project, and potentially franchise level. The role involves independently executing all statistical activities across the clinical development lifecycle and advising on advanced statistical design and methodologies. The position also contributes to regulatory submissions, innovation in statistical practices, and internal/external collaborations.
Lead and perform all statistical tasks for mid- to high-complexity clinical trials.
Develop protocols, Statistical Analysis Plans (SAP), and reporting documentation.
Support PK, PK/PD, biomarker, and exploratory analyses.
Propose and implement novel trial designs and statistical models.
Communicate statistical methods and findings to non-statistical stakeholders.
Serve as a core member of early project teams for low-complexity programs.
Drive data-driven decision-making in assigned indications.
Ensure quality and timeliness of statistical deliverables.
Collaborate across functions including data management, programming, and medical writing.
Contribute to global statistical and process improvement initiatives.
Lead or participate in internal process development, governance, and standardization efforts.
Participate in external scientific meetings, conferences, and peer-reviewed publications.
Represent Novartis in regulatory/statistical discussions.
Engage with external ethics committees and consultants when needed.
PhD in Statistics (or equivalent) with 5+ years relevant experience OR
MS in Statistics (or equivalent) with 7+ years relevant experience
Fluent in English (written and spoken)
Demonstrated ability to independently lead statistical activities at the trial level.
Strong knowledge of:
Clinical trial statistics
Regulatory requirements and HA guidelines
Bayesian methods, exposure-response modeling, biomarkers (as applicable)
Proficient in statistical software: SAS, R
Experience with statistical support for regulatory submissions and HA interactions.
Ability to clearly explain complex statistical concepts to diverse stakeholders.
Strong collaboration, project management, and matrix leadership skills.
Understanding of therapeutic areas, drug development processes, and industry trends.
Timely and high-quality delivery of statistical components for trials and projects.
Innovation and effectiveness in trial design and data analysis.
Cross-functional team feedback and project outcomes.
Contributions to publications, scientific presentations, and internal initiatives.
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people working together to change lives.
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Istanbul | Turkey |Norway :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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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 :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Richmond Hill | Australia | Mississauga | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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