343022BR
Aug 09, 2022
Japan

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Job Purpose:
The Senior Biostatistician is responsible for all statistical work for assigned trials and/or post-marketing surveillance (PMS) in Japan, and also takes on project level tasks as a Japan representative of biostatistics in the project team under limited supervision and in collaboration with the clinical trial team.

Activities include providing input on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments/surveillances, and production and delivery of statistical deliverables and exploratory analyses (may include PK, PK/PD analyses, exploratory biomarker and diagnostic analyses).

Main Responsibility:
a. Responsible for all statistical tasks on multiple assigned trials: trial de-sign/planning, statistical analysis plan, analysis for reporting activities, study report, exploratory analyses, and additional analysis to support publications.
b. Manage all statistical deliverables for the assigned trials/projects/experiments with quality and to agreed timelines.
c. Contribute to specifications of derived variables; statistical computing solu-tions for inferential statistical analyses; tables, and figures and listings shells.
d. Ensure that documents, specifications, programs/macros are consistent and comply with Health Authority requirements as well as project and Novartis standards.
e. 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.
f. Provide statistical analysis solutions when exploratory analyses are required. Implement novel methods and innovative trial designs with support from lead statistician and/or statistical methodology as required.
g. Responsible for all statistical tasks on the assigned PMS, including develop-ment of protocol and statistical analysis plan based on standardized tem-plates and reporting activities in collaboration with preferred vendors.



Why consider Novartis?
 
817million. 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.
 
ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

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:
MS (in Statistics or equivalent) with 2+ years relevant work experience or PhD (in Statistics or equivalent) with no work experience

Language:
Fluent English oral and written
Good communication and presentation skills

Experience/Professional Requirement:
1. Knowledge of / experience statistical software packages (e.g. SAS, R) with an expertise in at least one software.
2. Knowledge and expertise in Statistics.
3. Able to work with a multidisciplinary team to achieve team’s objective.
Global Drug Development
CD&A GDD
Japan
Tokyo
Research & Development
Full Time
Regular
No
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343022BR

Senior Biostatistician

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