外資製薬メーカー/Biostatistician/Senior Biostatisticianの求人【バイオ転職ナビ】

バイオ分野への転職は「バイオ転職ナビ」にお任せ下さい

Biostatistician/Senior Biostatistician 急募求人  /  外資製薬メーカー

ジョブNo.NJB1031412
職種 Biostatistician/Senior Biostatistician
社名 外資製薬メーカー
業務内容 <KEY TASKS & RESPONSIBILITIES>
-Functional Tasks
・As a trial biostatistician for statistically routine clinical trials, with limited direction provide statistical input for concept sheet/protocol/CRF development (e.g., trial design; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough statistics section; effective CRF specifications to collect data specified in the protocol), write medical and statistical supervision plans, write statistical analysis plans, provide analysis dataset specifications, and perform statistical analyses.
・As a trial biostatistician for statistically complex clinical trials, with direction provide statistical input for concept sheet/protocol/CRF development, write medical and statistical supervision plans, write statistical analysis plans, provide analysis dataset specifications, and perform statistical analyses.
・For integrated safety and efficacy summaries for regulatory submissions, with direction write statistical analysis plans and perform statistical analyses.
・For statistically routine clinical trials, with limited direction write comprehensive statistical methods sections for the clinical trial reports; review and co-author these reports ensuring the accuracy of the statistical interpretation.
・For statistically complex clinical trials, with direction write comprehensive statistical methods sections for the clinical trial reports; review and co-author these reports ensuring the accuracy of the statistical interpretation.
・May validate statistical output as required.
・Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation.
・Participate effectively on clinical trial teams.
・With direction, plan, communicate, and implement the surveillance of the statistical activities performed by a Contract Research Organization.
・Exhibit routine and complex problem solving skills.
・Keep abreast of statistical developments.
・Communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused and articulate manner.
・Understand and follow all Global Biostatistics WIs/SOP as well as any other relevant WIs/SOPs
-Managerial Tasks
求める経験 ・Preferably at least 3 years experience in the Pharmaceutical/Biotechnology industry in clinical development
・Working SAS knowledge
・Knowledge of relevant regulatory guidelines applicable to clinical development
・Familiarization with or ability to develop an understanding of relevant therapeutic areas

語学力 英語力:中級
勤務地
東京都
年収 900万円 - 1200万円
雇用形態 正社員(期間の定めなし)

※掲載中の求人は紹介会社やタイミングによって異なります

バイオに最適な求人をご紹介しますので
ますは転職サポートにお申込みください。

転職サポートに申し込む

25,396名の若手~経験豊富なスペシャリストが
転職ナビに登録しています。

2015年の1年間の実績です

転職ナビは専門性を持つ、あるいは強化していきたい方向けに250以上のスペシャリスト向けサイトを提供。毎月3,000名以上のご登録があります。

あなたの専門性に注目・応援

転職ナビを運営するアスタミューゼでは、2006年から一貫して、専門的な経験を活かしていきたい方のキャリアを全力で応援しています。

「この求人はあまりピンとこない」という方

以下のような求人をお探しではありませんか?

  • 人気企業(大手企業・優良企業)や人気業種
  • IPO要員や新規事業立ち上げなど重要度なポジション
非公開求人円グラフ
こうした求人の多くは、一般には公開されない「非公開求人」のため、サイトには掲載できません。

限られた緊急・極秘案件に関連する誰も知らない求人があります。

極秘求人の紹介を受ける

Biostatistician/Senior Biostatisticianと似た条件の案件を探す

このページで紹介しているBiostatistician/Senior Biostatisticianと似た条件の求人情報を探すにはこちらから

Product Manager_Bone

<Main purpose of Job> Marketing Manager position leading bone osteoporosis access marketing initiatives and programs for romosozumab. Candidates must have a proven track record of sales success and/or marketing experience developing and implementing a wide range of high-impact marketing tools and programs. <Responsibilities> Contributes Japanese Brand Plan development Manages the relationships with co-promotion partners to maximize the value of co-promotion scheme Develops and executes sales promotional activities in alignment with co-promotion partners Coordinates and leads meetings with co-promotion partners Engages and involves sales leadership in planning and key initiatives Develops programs and tools for optimal sales force effectiveness Partners with the Medical Communication Manager in the development and execution of the Medical Affairs and Promotional Program Establishes regular contacts with key opinion leaders Develops regional congress plans Collaborates with colleagues in other Expansion Markets and corporate office as needed on joint projects.

Study Manager, Clinical Operations (炎症・免疫)

<Summary/Scope> The Study Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, JGCP, Regulatory Authorities’regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional Japan study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO). Study manager has full responsibilities for studies led by the Japan Study Team. Responsibilities in the global study is complied with Affiliate Involvement Model (AIM), Job aid and direction given by Global Clinical Trial Manager (CTM). Responsibilities involve a combination of execution and oversight-dependent on the sourcing model - to ensure deliverables and may include, but are not limited to, the following: -Financial Planning and Management ・Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget ・Takes ownership and accountability for the development/management/reconciliation of overall study budget(s) ・Development/management of vendor scope of work (SOW) per contract, quality, and budget ・Review/approval of vendor invoices and management of accruals and SOW changes ・Review/approval of site invoices and management of site budget -Project Management ・Drive study execution ・Oversight of clinical monitoring quality and adherence to established processes and plans ・Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions ・Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs. ・Maintenance/updating of data as appropriate in project management tools including CTMS ・Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation -Study Planning and Conduct ・Facilitation of site feasibility/selection processes with use of robust data ・Operational and strategic input into study documents such ……(以下詳細は面談時にご案内します)

薬事(管理職)

<担当する仕事内容の詳細> ・承認申請書類、届出書類等の薬事監査 ・GVP、GQP自己点検 ・製造販売中止製品の承認整理、後発医薬品の薬価基準収載手続き及び削除 ・薬事規制の対象となる添付文書、製品のパッケージ、広告等の監査 ・薬事規制に係る情報等の収集・分析及び関係部署への情報提供 ・薬事に係る相談と助言等

関連カテゴリから探す

急いで転職したい方

求人のご提案から、面接・内定まで徹底的に支援

無料転職サポートの特長

「無料転職サポート」は便利そうですが、一方的に電話がかかってきたり、本意でない転職を無理強いされたりしないか不安です。

お客様のご希望を無視したしつこいご連絡や無理強いは一切いたしません。お客さまにとってご納得いただけるプロセスで転職活動を進めていただくことが第一と考えております。

じっくり転職したい方

転職のプロがあなたにぴったりの求人をご紹介

キャリアコンサルタントに求人を紹介して貰う(無料)

あなたのご検討に役立つ幅広い選択肢をご提供

求人を自分で見極める(無料)