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求人掲載はこちら

  1. 日本語を使って働きたい人のための求人サイト
  2. 東京 で仕事を探す
  3. Sr Biostats

Sr Biostats

800 〜 1000 万円

  • RGFタレントソリューションズ株式会社
  • 勤務地: 東京
  • 日本語レベル:流暢に話せるレベル │実務経験:未分類
  • 掲載終了
掲載期間:2019/11/19~2020/05/17

仕事概要

職種 技術職(販売、設計、開発、生産管理)/開発、研究、実験、プロジェクトマネージャー
業種 医療/ その他医療
雇用形態 未分類
ポジションレベル その他
募集人数 1名
希望入社時期 -
必須語学力

英語 (ビジネスレベル)

日本語 (流暢に話せるレベル)

活かせる語学 -
勤務時間 その他
福利厚生・休暇
ビザ取得支援 -
外国人従業員 -

仕事詳細

Company Overview
Global CRO

Job Description
 Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
 Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
 May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
 Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.  Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
 Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
 Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
 Implements company objectives, and create alternative solutions to address business and operational challenges.
 Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.  Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
 Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management.
 Provides statistical programming support as needed.
 May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
 May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
 Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
 Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
 Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
 Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
 Coaches and mentors other Biostatistics staff.
 Performs other work-related duties as assigned.
 Minimal travel may be required.

Requirements
 Graduate degree in biostatistics or related discipline.
 Moderate experience in clinical trials or an equivalent combination of education and experience.
 Proficiency in programming.
 Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
 Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
 Excellent written and verbal communication skills.
 Ability to read, write, speak, and understand English.

面接について

連絡先

日本東京 地図



担当者名:

Sr Biostats

RGFタレントソリューションズ株式会社

800 〜 1000 万円

掲載終了

会社概要

RGFタレントソリューションズ株式会社 Sr Biostats RGFタレントソリューションズ株式会社 Sr Biostats

RGFタレントソリューションズ株式会社

人材、教育、コンサル、専門サービス /人材紹介、求人広告

RGF Professional Recruitment Japanは、日本最大規模の人材総合サービスカンパニー リクルートの海外展開ブランドにおける人材紹介部門の日本拠点です。日本国内でビジネスを展開する外資系企業並びにグローバル企業様を中心に、幅広いレベルのバイリンガル人材をご紹介しています。リクルートブランドとアジアの主要都市を網羅するRGFのネットワークを活かし、転職を希望される方、クライアント企業様双方にとって最適なサービスをご提供いたします。



RGF Professional Recruitment Japanの事業領域

RGF Professional Recruitment Japanはジュニアレベルからマネジメントレベルを中心に、すべての業種、職種の案件を取り扱っています。また、8,000,000を超える業界屈指の人材データベースから、大手外資系企業、グローバル企業に対して業界トップレベルの人材をご紹介することが可能です。

RGFプロフェッショナルリクルートメントジャパン
東京都品川区大崎2-1-1 ThinkPark tower 6階
(+81)3-6422-4400

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