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部署・役職名 | 外資大手製薬メーカー:Statistician |
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職種 | |
業種 | |
勤務地 | |
仕事内容 |
The Position As the Statistician, you will be accountable for all statistics within the designated projects/trials and optimize the clinical development plan statistically. You will complete the protocol, statistical analysis plans (SAP), data handling, clinical trial report (CTR), common technical document (CTD) and regulatory documents statistically. You will also drive Case Report Form (CRF), Trial Validation Plan (TVP), CTR data flow plan input, CTR workflow plan, Statistical Programming Specification (SPS) as well as perform statistical analysis and programming of output according to specification. Other tasks include, but are not limited to: ・Drive trial outline (TO) development including sample size calculation, protocol development including statistical section of protocol. Support to derived programming according to industry standards. Interpret trial results and present results for the project and upper management. Day-to-day trial execution and coordination within the trial stats team. Ensure project statistical programming specification input and statistical input to design of trial. ・Do presentation and negotiation of clinical development program at meetings with regulatory authority/Pharmaceuticals and Medical Device Agency (PMDA). Develop submission document(s), and post-submission activities to achieve regulatory approval and optimal labelling to allow the successful launch of the drug. ・Share better practices and increase awareness of statistics within the designated projects and Clinical Medical Regulatory development division. Act a part of the standardization and globalization of the statistical activities. ・Be responsible for continuous development of own skills (statistical knowledge, English communication skill, needed training and education) according to individual development plan (IDP). ・Keep Headquarters up to date on PMDA requirements on electronic data submission, review e-data consultation documents by checking e-data to submit to PMDA and coordinate e-data consultation. |
応募資格 |
【必須(MUST)】 ・Minimum master’s degree of Science in Statistics or equivalent.・Minimum of 3 years of experience as a statistician within the pharmaceutical area or equivalent knowledge through relevant experience. ・Good knowledge of Good Clinical Practice (GCP) and statistical guidelines within drug development. ・Experience with a broad range of statistical tasks, statistical software, and in-depth experience with at least one statistical software package. ・Experience with communication of statistical issues and presentations. |
アピールポイント | 自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 創立30年以上 産休・育休取得実績あり ストックオプション制度あり 教育・研修制度充実 |
リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
受動喫煙対策 | 屋内禁煙 |
更新日 | 2023/11/17 |
求人番号 | 2724301 |
採用企業情報
転職・求人情報の詳細をご覧になる場合は会員登録(無料)が必要です