Job Description

Job ID
363822BR

Feb 10, 2023

India

40+ analysis including trials, analysis, health authority responses, publication requests, access services, etc, are being worked upon at any point of time. The Statistical Programming team is a function where we are empowered to experiment, explore and progress beyond the boundaries of outstanding Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.

Job Purpose

The Senior Biostatistician will be responsible for delivering statistical analytic solutions for Medical Affairs studies (MA), Non-Interventional studies (NIS), Scientific Analytics studies and multiple Phase I-IV clinical trials at a trial level by performing statistical analyses plans, ensuring high quality and timely production of statistical reporting results (analysis datasets, tables, listings and graphs).Emphasis will be placed on leading studies and initiatives, advising the customer and providing insights on all statistical aspects of the studies. Supervise CROs as required and ensure timely results.

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

• Responsible and accountable for activities and support on statistical solutions for trials/publications and conferences including assigned RWE studies. Activities include providing input on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical results. Train the protocol, CRF, SAP and mocks before programming starts and ensure that the project team understands the study.

• Responsible for transcribing analysis plans into computational solutions for the statistical programmer to implement (specifications of derived variables, specification and statistical computing solutions for inferential statistical analyses, tables and listings templates for key reporting documents like the CSR) of Phase I-IV clinical trials.

• Ensure that documents, specifications, programs/macros are consistent and align with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities. Ensure that documents related to randomization, blinding, unblinding comply and collaborate with Random Office in NVS.

• Responsible for protocol inputs, concept sheet, sample size calculation, de-identification if required, review CSR, and development of Appendix 16.1.9 in CSR. Responsibilities include, leading statistical result meetings with vital clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses.

• Lead study teams to ensure high quality for all assigned results and expect excellent knowledge of processes and ensure audit-readiness. Responsible to plan strategies to avoid AQWA. Provide input on process improvement initiatives and participate in non-clinical project activities with support from group head.

• 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. Provide statistical analysis solutions when exploratory analyses are required. Support quality control and quality audit of deliverables.

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

Education: (minimum/desirable):

• MS/ MSc (in Statistics or equivalent) with 5+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years of work experience.

• Working knowledge of/experience with SAS/ R or any other business or research analytic software with an expertise in at least one type of software.

• Statistical and numerical knowledge and expertise in analytic aspects.

• Excellent interpersonal and communication skills. Strong understanding of global clinical trial practices, procedures, methodologies.

• Strong understanding of regulatory requirements for design, analysis and reporting of clinical trials.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s 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\xe2\x80\x99s 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: https://talentnetwork.novartis.com/network


Division
CTS
Business Unit
CONEXTS
Location
India
Site
Hyderabad, AP
Company / Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No