Biostatistician & Data Science | ヘイズ・スペシャリスト・リクルートメント・ジャパン株式会社/Hays Specialist Recruitment Japan K.K.の求人詳細


キービジュアル キービジュアル
更新日 2019-03-28
掲載開始日 2018-07-31

Biostatistician & Data Science

  • ★★ スタッフレベル
ヘイズ・スペシャリスト・リクルートメント・ジャパン株式会社/Hays Specialist Recruitment Japan K.K.
企業名 会社名非公開
ヘイズ・スペシャリスト・リクルートメント・ジャパン株式会社/Hays Specialist Recruitment Japan K.K.
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
IT関連(組込み/制御系) - プログラマー
メディカル/医薬/バイオ/素材/食品 - その他
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 Act as (associate) Trial Statistician (TSTAT) or (associate)Trial Statistician-Translational Medicine and Clinical Pharmacology (TSTAT-TMCP) for routine phase I-IV clinical trials

The responsibilities cover, e.g.:
- writing the statistical section of the clinical trial protocol
- reviewing case report forms
- specifying/reviewing the randomization
- presenting critical statistical aspects at investigators meetings
- preparing the trial statistical analysis plan
- supervising the analyses
- interpreting and communicating the results
- participating in the writing of an accurate, high quality clinical trial report and of publications thereof.

・Timely availability and quality of trial deliverable as outlined in the TSTAT task list.
・Feedback from other team members within function and across functions.

May also need to act as PSTAT-Asia for projects with established BI experience.

The responsibilities of a PSTAT-Asia cover, e.g.:
- collaborate with PSTAT, TMM, TMM Asia (if appointed), PCPK Asia (if needed) in developing the clinical development plan and core project elements to approach Asian regional issues in line with regulatory requirements/recommendations
- collaborate with PSTAT to the project statistical analysis plans from regional perspectives
- collaborate with PSTAT-TMCP and PCPK Asia to plan and supervise all meta-analyses/pooled analyses of PK, PD and biomarker data to support submissions in China and Japan
応募条件 <Required Skills>
Special Skills
- Good oral and written communication skills
- Sound knowledge of statistical methodology, design of clinical trials and on processing clinical trial information
- Ability to pro-actively identify data issues and solutions and to interact with internal and external bodies (specialists and non-specialists) on routine statistical/methodological issues at the trial level
- Ability to supervise scientific/technical work at the trial level
- Ability to write publications (as joint author) of clinical trials or on relevant statistical topics

<Special working experiences>
General work experience:
- Doctoral degree: None
- Masters degree: Three years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions

<Language Skills & Proficiency>
Japanese: Native
English: Business (need to be able to communicate with counterparts in foreign countries)

<Required education>
Master's degree or above in Statistics or Mathematics or related field
英語能力 ビジネス会話 (TOEIC 735-860)
日本語能力 流暢(日本語能力試験1級又はN1)
年収 日本・円 700万円 以上   
給与に関する説明 福利厚生が充実。住宅手当、医療手当てあり。ワークライフバランス重視の環境




ヘイズ・スペシャリスト・リクルートメント・ジャパン株式会社/Hays Specialist Recruitment Japan K.K.




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Biostatistician & Data Science