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[Innovative Medicine] R＆D, Senior Programing Lead, Clinical ＆ Statistical Programming Japan

年収：800万 ～ 1000万

採用企業案件

採用企業

ヤンセンファーマ株式会社

  • 東京都

    • 会社規模501-5000人
  • 医薬品メーカー
部署・役職名 [Innovative Medicine] R＆D, Senior Programing Lead, Clinical ＆ Statistical Programming Japan
職種
業種
勤務地
仕事内容 ■Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

■Position Summary:
The Senior Programming Lead is an experienced programmer with an advanced knowledge of programming languages, has expertise in industry standards, complex data structures and programming methods, having the technical capabilities in leading trial activities in accordance with departmental processes and procedures.
The Senior Programming Lead for Post‑Marketing Surveillance (PMS) drives the standardization of PMS programming processes conducted by external vendors, workflows, dataset specification templates, and data presentation specification (DPS) templates for PMS studies; develops and maintains reusable PMS code/specifications for acceptance confirmation as a sponsor; and delivers high‑quality PMS outputs (e.g., analysis datasets, tables and listings) in partnership with Statistics, Data Management, Post Approval Delivery Unit, and external vendors. The role oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. The role plans and manages end‑to‑end PMS programming projects - defining scope and timelines, coordinating resources, providing hands‑on technical direction, and ensuring adherence to applicable PMS regulations and internal SOPs.

■Principal Relationships:
This role reports into a people manager position within the C&SP Japan
PMS-related collaborators include but are not limited to: Statistics, Data Management, Post Approval Delivery Unit and external vendors.
応募資格

【必須（MUST）】

■Education and Experience Requirements:
Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth).

■Experience and Skills Required:
Approx. 4+ years programming experience with increasing responsibility preferably in PMS environment.
Hands-on experience handling PMS studies, with knowledge of applicable PMS regulations; experience with standardized dataset specification/DPS templates and deliverables (e.g., datasets, tables and listings, relevant documents).
Knowledge of programming practices (including tools and processes).
Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. Knowledge of SAS is required.
Demonstrated written and verbal communication skills in English.
Experience in planning and coordinating programming activities and leading teams.
Experience working with cross functional stakeholders and teams.
Experience in vendor management oversight.
Project management skills and knowledge of team management principles.
Working knowledge of post-marketing regulatory requirements relevant to statistical analysis and reporting

【歓迎（WANT）】

Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.
Expert CDISC Standards knowledge.
Advanced Analytics, Biostatistics, Clinical Trials, Collaborating, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy

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更新日 2026/02/06
求人番号 7230081

採用企業情報

ヤンセンファーマ株式会社
  • ヤンセンファーマ株式会社

  • 東京都

    • 会社規模501-5000人
  • 医薬品メーカー

  • 会社概要

    私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
    ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
    満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
    さんの手元に届けることができるよう取り組んでいます。

    私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
    （Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
    ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
    神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
    かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
    ライフ）の向上を目指した支援活動などをおこなっています。

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