Job Description

389739BR

Principal Biostatistician

India
About the role
Principal Biostatistician

Location: Hyderabad, India #LI-Hybrid

About the Role:

The Principal Biostatistician will be responsible and accountable for the statistical activities and support on statistical solutions for studies/publications and conferences. Support the tasks independently seeking peer inputs/ reviews which includes protocol development in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, sample size estimation, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses.

Ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for Interventional and Non-Interventional Clinical studies.
Maintain efficient interfaces with other statisticians, internal and external customers, CROs and CPOs as needed.
Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.

Key Responsibilities:

• Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
• Excellent knowledge of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software.
• Good understanding of global clinical trial practices, procedures, methodologies and deep knowledge of data architecture
• Statistical and numerical knowledge and expertise in analytic aspects and applications in clinical trials.
• Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
• Good understanding of drug development, regulatory requirements, ICH and HA guidelines

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:

• Education: MS/ MSc (in Statistics or equivalent) with 8+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ years of work experience.
• Good communication and presentation skills

Desirable Requirements:

• Pharmaceutical industry domain knowledge

Why Novartis? Our purpose is to reimagine medicine to improve and extend people\xe2\x80\x99s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You\xe2\x80\x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams\' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Operations
Business Unit
Global Business Solutions
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No