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Principal Biostatistician

Hyderabad, India
Closing date
Jun 1, 2023

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Science, Mathematics and Statistics, Pharmaceutical
Full Time
Organization Type
Jobseeker Type
Job Description

200+ compounds in Novartis are supported by bio statisticians in 10+ sites around the globe. Biostatisticians transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. They influence decision-making in cross-functional international teams from early to late phase drug development. Come to an industry leader where you will be responsible for all statistical work, scientific and operational, in collaboration with the clinical trial team. You will have the opportunity to support trial/project/disease-level deliverables for clinical development/research projects with supervision. You will develop and implement modern and innovative clinical trial/experimental designs, statistical methodology in collaboration with a cross-functional team.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation.

• Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.

• Franchise or Global Line Function level: Contribute to initiatives at global line function level.

• Enterprise level: Participate in non-clinical project activities as needed. Contribute to the review and implementation of health authority suggestions. Promotes the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings

• External level: Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.

• People Management: Mentor new hires and/or junior Statisticians.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Minimum Requirements:

• MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship).

• Good communication and presentation skills.

• Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.

• Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g., SAS, R).

• Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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:

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