REQ-10069927
Ene 19, 2026
Japón

Summary

The Senior Statistical Programmer is responsible for all statistical programming aspects of assigned studies or project-level activities. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis are executed efficiently with timely and high quality deliverables.

About the Role

About the Role

Key Responsibilities:

  • Lead statistical programming activities for Phase I–IV studies and project‑level tasks, ensuring high‑quality planning and execution.
  • Coordinate internal and external programmers, providing study‑level programming recommendations and contributing to project standards.
  • Collaborate effectively with cross‑functional teams, communicating timelines, scope, and deliverable status as a Clinical Trial Team (CTT) member.
  • Develop and validate high‑quality analysis datasets and outputs (CSRs, regulatory submissions, safety reports, publications) in compliance with CDISC and internal standards.
  • Drive continuous improvement by maintaining up‑to‑date knowledge of programming tools/industry standards and contributing to process optimization initiatives.

Education (minimum/desirable):
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field

Essential Requirements:

  • R または SAS のエキスパート(どちらかまたは両方の臨床試験での実務経験5年以上目安)
  • CDISC標準を理解し,SDTM/ADaMの設計・実装・レビューを自立して主導できる
  • 臨床試験・申請業務でのプログラミング実務経験5年以上
  • PMDA E-data submissionの実務経験
  • Trial programmer(CROであればProgramming teamのリード)としてプロジェクトのプログラミングチームに対するリード経験

Desirable Requirements:

  • 解析帳票の設計及びQCの計画が策定できる
  • リソース管理・スケジュール管理などのプロジェクトマネジメント(担当プロジェクトのプログラミングチームに対して)
  • Rパッケージ開発
  • SAS,R以外の言語(Python等)
  • 書面調査対応の経験
  • DB調査の経験
  • 業務改善・効率化などを念頭に置いたツール開発
  • PMS業務の経験

Launguage:

  • 日本語での円滑な他部門(統計担当者,DM担当者等)との連携ができる
  • 英語(読む・書くは問題なくでき,口頭でのコミュニケーションも可能)

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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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

Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer- r.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

<JP>

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多様性と包括性へのコミットメント: ノバルティスは患者さんや地域社会などに対して、包括的かつ優れた職場環境、および多様なチームを構築するよう取り組んでいます。

合理的配慮: ノバルティスは障害を持つ個々人に対して、合理的配慮を提供し協働することをお約束します。健康状態や障害に関して、採用プロセスあるいは必須の職務を満たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com 宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Development
Development
Japón
Toranomon (NPKK Head Office)
Research & Development
Full time
Regular
No
Thriving together - Our story. VIDEO

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

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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REQ-10069927

Senior Statistical Programmer

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