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16 listing(s) available.

  • 05 Mar 2019

    Statistician Biostat & Data Science JP Dept, Medical Div. / 医薬開発本部データサイエンス部統計解析グループ

    Japan

    Permanent Position
    ベーリンガーインゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    《Basic Purpose of the job》

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

    or

    Act as associated TSTAT or TSTAT-TMCP for complex phase I-IV clinical trials

    or

    Act as associated Project Statistician (PSTAT) supporting the responsible T/PSTATs or T/PSTATs-TMCP or PSTATs-Medical Affairs (PSTATs-MA) for projects with established BI experience

    or

    Act as PSTAT-Asia for projects with established BI experience

    《Accountabilities》

    1.Act as TSTAT or TSTAT-TMCP for routine clinical trials with existing statistical standards.

    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 deliverables as outlined in the TSTAT task list. 

    ・Feedback from other team members within function and across functions.

    2.Support other TSTATs or TSTATs-TMCP in their responsibilities. 

    Support PSTATs, PSTATs-TMCP or PSTATs-MA in their respective responsibilities.

    ・Feedback from supported functions.

    3.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

    - take on key statistical responsibility in the planning and preparation of regulatory submissions in Asian countries 

    - participate in the writing of the integrated summary documents for submissions in Asian countries and of publications thereof

    - participate in internal presentations for management decisions on further development steps in Asia

    - provide and organize statistical support for regulatory meetings, questions and submissions in Asian countries

    - represent the company in negotiations with regulatory agencies in Asia or other external decision making bodies on statistical-methodological issues relevant to Asian development/submissions

    - actively contribute to the MSTs 

    - support the lead PSTAT or PSTAT-TMCP on the project by keeping him/her informed constantly and by contributing to the submission; OR 

    - collaborate with PSTAT-MA and TM-MA in developing the market access strategy in Asian countries

    - collaborate with PSTAT-MA on continued safety surveillance and monitoring of the benefit-risk balance of product in Asian countries 

    - collaborate with PSTAT-MA and Global Epidemiology to identify real world data gaps and needs as well as to plan and analyze non-interventional studies in Asia.

    ・Timely availability and quality of project deliverables according to internal and formal timelines.

    ・Feedback from other team members within function and across functions incl. outside experts and regulatory authorities.

    ・Availability and use of efficient standards.

    ・Acceptance of development plans and submissions by regulatory authorities.

    ・Acceptance of publications by journals.

    4.Prepare specifications for data analyses of routine clinical trials by outside vendors. Assure compliance with the specifications by reviewing the vendors' products. Release of vendor’s product.

    Assist other statisticians in preparing specifications for data analyses of complex clinical trials by outside vendors. Assist other statisticians in assuring compliance with the specifications by reviewing the vendors' products.

    ・Timely availability and quality of specifications as well as level of compliance of vendor’s product with the specification.

    5.Provide necessary statistical and programming support needed for data mining and ad-hoc analyses within one or across several trial(s).

    ・Timely availability, quality and adequacy of data mining, ad-hoc or exploratory analyses.

    6.Support management in resource planning and tracking for assigned trials.

    ・Quality of data in the respective Clinical Trial Management System. 

    ・Level of pro-activity in sharing resource deviations from planned versus actual dates

    7.Supervise contract research organizations (CROs) for all statistical tasks with emphasis on analysis related processes. Prepare oversight plan. Assure compliance with the specifications by reviewing the CRO's products.

    ・Timely availability and appropriateness of oversight plan as well as level of compliance of CRO’s product with the specification.

    Expires on 13 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    <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

    In addition for PSTAT-Asia:

    - Ability to successfully plan and conduct submissions for Asian countries including China and Japan for projects with established BI experience

    - Ability to successfully plan and conduct statistical activities to support market access activities, continued safety surveillance and monitoring of the benefit-risk balance of product, and non-interventional studies in China and/or Japan


    <Special working experiences>

    General work experience:

    - Doctoral degree: None

    - Masters degree: Three years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions

    Specific experiences:

    - Demonstrated ability to conduct and analyze a routine clinical trial under the supervision of a more senior statistician

    - Experience with communication and presentation of statistical information to non-statisticians

    - Evidence of strong teamwork at trial level

    <Language Skills & Proficiency>

    Japanese: Native level

    English: Business

    <Required education>

    Degree / education:Masters degree (e.g. MBA, MSc) or Doctoral degree (e.g. PhD, MD)

    Major, focus:Statistics or Mathematics or related field 

  • 25 Feb 2019

    Project Statistician (担当/担当課長/専門課長)

    Japan

    Permanent Position
    アメリカ系製薬企業 - 1876年に創業、140年を超える歴史がある。米国インディアナ州インディアナポリスに本社を置く、革新を追求する医薬品のリーディング・カンパニーです。世界各国の自社研究施設や外部の優れた科学的研究機関との提携による最新の研究成果を用いて、各治療領域で最高レベルの豊富なポートフォリオの医薬品を開発しています。世界120ヵ国以上で事業を展開しています。

    Job Description

    【職務概要/Overall Job Purpose】
    Provide strong statistical leadership in the process of drug development.
    The Project statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.


    【主な職責/Primary responsibilities】
    Statistical Trial Design and Analysis
    ● Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
    ● Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
    ● Collaborate with data management in the planning and implementation of data quality assurance plans.
    ● Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
    ● Participate in peer-review work products from other statistical colleagues.

    Communication of Results and Inferences
    ● Collaborate with team members to write reports and communicate results.
    ● Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
    ● Respond to regulatory queries and to interact with regulators.

    Therapeutic Area Knowledge
    ● Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

    Regulatory Compliance
    ● Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.

    Expires on 13 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須経験(Required Experience (mandatory for hiring)】
    ◆ M.S. or Ph.D. in statistics or biostatistics.
    or
    ◆ Rich experiences in healthcare field as a statistician with science background such as mathematics or epidemiology.

    ◆ Ph.D. more preferable


    【望ましい経験/Desirable Experience】
    ◆ Experiences of collaboration with team outside of Japan (preferred: overseas living experience)


    【必須応募資格/Essential skills and license (mandatory for hiring)】
    ◆ Statistical and methodological knowledge in clinical development, epidemiology or related field.
    ◆ Regulatory knowledge of clinical trial methodology and statistics. 
    ◆ Ability to build relationships with individuals and teams.
    ◆ Strong English and Japanese communication and presentation skills


    【望ましい資格/Desirable skills and license】
    ◆ Proficient in the SAS programming language 

  • 15 Feb 2019

    東京 臨床統計解析(経験者の方)

    Japan

    Permanent Position
    EPS - 日本のCROのパイオニアとして、1991年の創業以来、四半世紀にわたって、新薬開発支援等の多彩なソリューションを提供し、医療・ヘルスケア産業の発展に貢献してきました。

    Job Description

    《職務内容》
    臨床試験データの統計解析。統計解析報告書、研究会資料の作成など。

    Expires on 13 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    *統計解析経験者
    ・医薬品開発業界での統計解析実務経験者 

    給与は経験・能力・資格等考慮し、弊社規程に則して決定します。

  • 15 Feb 2019

    大阪 臨床統計解析(経験者の方)

    Japan

    Permanent Position
    EPS - 日本のCROのパイオニアとして、1991年の創業以来、四半世紀にわたって、新薬開発支援等の多彩なソリューションを提供し、医療・ヘルスケア産業の発展に貢献してきました。

    Job Description

    《職務内容》
    臨床試験データの統計解析。統計解析報告書、研究会資料の作成など。

    Expires on 13 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    *統計解析経験者
    ・医薬品開発業界での統計解析実務経験者 

    給与は経験・能力・資格等考慮し、弊社規程に則して決定します。

  • 15 Feb 2019

    名古屋 臨床統計解析(経験者の方)

    Japan

    Permanent Position
    EPS - 日本のCROのパイオニアとして、1991年の創業以来、四半世紀にわたって、新薬開発支援等の多彩なソリューションを提供し、医療・ヘルスケア産業の発展に貢献してきました。

    Job Description

    【職務内容】
    臨床試験データの統計解析。統計解析報告書、研究会資料の作成など。

    Expires on 13 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    *統計解析経験者
    ・医薬品開発業界での統計解析実務経験者 

    給与は経験・能力・資格等考慮し、弊社規程に則して決定します。

  • 15 Feb 2019

    【経験者】統計解析

    Japan

    Permanent Position
    シミック - 1992年に日本で最初にCRO(医薬品開発支援)というビジネスを開始致しました。 近年では、医療・医薬品を取り巻く環境はめまぐるしく変貌し、国境の垣根を越えた開発競争、M&Aや異業種からの参入など、かつてないほどに業界再編の動きが激化しています。それに伴い、製薬企業を中心とするお客様のニーズも多様化・高度化していますが、私たちはそのニーズを迅速かつ的確に捉え、お客様の期待以上のサービスを提供できるよう活動してまいります。

    Job Description

    【職務内容】

    臨床試験データの統計解析
    統計解析計画の立案、SASを使用した統計解析実務

    Expires on 13 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須要件】
    •製薬メーカーまたはCROでの統計解析業務、および統計解析に関する計画の立案等の実務経験5年以上
    (SASプログラミングのみの経験は不可)
     

    【歓迎要件】
    •コミュニケーション力
    •英語力


    給与は前職考慮の上で決定いたします

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