Principal Biostatistician
Nov Hltcr Shared Services Ind
Hyderabad, AP, India
1d ago

Your responsibilities :

Your responsibilities include, but are not limited to :

1. Study level :

a. 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.

b. 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.

c. 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.

d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials.

e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions / decisions / statements as required.

f. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.

g. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and / or non-clinical related activities.

2. Project level :

a. Contribute to project level activities as needed.

b. Contributes to project team preparation for HA Advisory Committees and meetings.

3. Enterprise level :

a. Participate in non-clinical project activities as needed

b. Contribute to the review and implementation of health authority guidances

c. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings

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) Fluent English (oral and written) Good communication and presentation skills.

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

2. 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.

3. Experience in Franchise / Therapeutic Area and / or regulatory activities desirable.

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

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