Senior Biostatistician (Mandarin)

330802BR
Dec 16, 2021
Malaysia

Job Description

“17! This is the number of countries & regions we are supporting in 2021 as Biometrics team. We provide expertise in locally/regionally/globally initiated clinical trials such as data management, Biostatistics consulting, statistical programming, medical writing and more!“
As a 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 executing statistical analyses plans, ensuring high quality and timely production of statistical reporting deliverables (analysis datasets, tables, listings and graphs).
Your responsibilities include, but are not limited to:
• Responsible and accountable for the statistical activities and support on statistical solutions for trials/publications and conferences. 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 deliverables and exploratory analyses.
• Responsible to arrange kick-off meeting for a project and ensure to complete project specific trainings for the team. 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 development of 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 comply 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 with company standards and collaborate with Random Office in NVS. Assume the responsibility of an independent statistician in a study as per requirement.
• Responsible for protocol inputs, concept sheet, sample size calculation, de-identification if required, review CSR, and development of Appendix 16.1.9 in CSR.
• Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with vital clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Encouraged to provide support for publications for individual clinical trials, and scientific analytical solutions.
• Lead study teams to ensure high quality for all assigned deliverables and expect excellent knowledge of processes and ensure audit-readiness.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you‘ll bring to the role:
• 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
• Proficient in English and Mandarin (oral and written).
• Solid understanding 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.

About the Novartis Global Service Center in Kuala Lumpur:

The Novartis Global Service Center (NGSC) in Kuala Lumpur delivers a broad variety of services to the Novartis divisions worldwide. Kuala Lumpur is part of a globalized network of five NGSCs, which form a successful network of services minded associates partnering with the Novartis business around the world.

What makes NGSC special?

Attractive office location, flexible time management, strong work/life balance, flexible working hours, truly multinational and dynamic organization, multicultural environment and cross-functional hub location


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 learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
CTS
NBS CONEXTS
Malaysia
Petaling Jaya
Research & Development
Full Time
Regular
No
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330802BR

Senior Biostatistician (Mandarin)

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