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【Alexion】Senior Manager, Biostatistics
年収：1000万 ～ 1400万
採用企業案件
アレクシオンファーマ合同会社
-
- 会社規模非公開
- 医薬品メーカー
- その他
| 部署・役職名 | 【Alexion】Senior Manager, Biostatistics |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
This is what you will do: The Senior Manager Biostatistics is responsible for statistical activities in support of clinical trials and NDA submission, including but not limited to the following: contributing to development strategies, trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. You will be responsible for: ・ Collaborates with Global Biostatistics, Japan Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials and to plan development strategies. ・ Writes and/or reviews the statistical sections of clinical trial protocols, while consulting with internal and external experts ・ Contributes to or prepares statistical analysis plans and Data Presentation Plans ・ Collaborates with Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on design of eCRFs ・ Provides statistical guidance on conduct of ongoing trials ・ Collaborates with Statistical Programmers on summary and analysis of trial data. Writes and/or reviews ADS and ad hoc analysis specifications ・ Contributes to clinical study reports, CTDs and other regulatory documents e.g. DSURs, Briefing Documents, etc. ・ Contributes to scientific articles, summarizing data collected in Alexion trials. ・ Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed. ・ Consults with Research & Preclinical colleagues on statistical questions in their work. ・ Manages CRO statistical and programming support. |
| 労働条件 |
標準勤務時間：9:00～17:15（フルフレックス制） 完全週休2日制（休日は土日祝） 年間有給休暇4日～20日（初年度の付与日数は入社月によって按分） 年間休日日数123日（2025年） 年末年始、年次有給休暇、慶弔休暇、リフレッシュ休暇、看護休暇、介護休業 他 年次有給休暇：入社初年度1‐3月入社:16日、4‐6月入社:12日、7‐9月入社:8日、10‐12月入社:4日 ※2年目以降20日 ■法定社会保険制度（アストラゼネカ健康保険・厚生年金保険・雇用保険・労災保険） ■永年勤続表彰 ■福利厚生（リスクベネフィット・グループ保険・財形貯蓄・リロクラブ） ■育児・介護休業 |
| 応募資格 |
【必須（MUST）】 ・PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience. ・ Excellent written and oral communication skills ・Excellent presentation and interpersonal skills ・ Experience programming in SAS ・ Experience with simulations (design, implementation and interpretation) ・ Understanding of ICH GCP as well as general knowledge of industry practices and standards ・ Familiarity with R programming language and other statistical software, including EAST ・ Experience with CDISC, including SDTM, ADaM, CDASH ・ Flexible, well-organized, and possess the ability to work well under pressure. ・ The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 【歓迎（WANT）】 We would prefer for you to have:・ PhD in Statistics/Biostatistics preferred. |
| 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 上場企業 従業員数1000人以上 シェアトップクラス 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2026/03/12 |
| 求人番号 | 7760001 |
採用企業情報
- アレクシオンファーマ合同会社
-
- 会社規模非公開
- 医薬品メーカー
- その他
-
会社概要
【設立】1992年
【代表者】濱村 美砂子
【本社所在地】東京都港区芝浦3丁目1番1号
【事業内容】
希少疾患治療薬の開発及び販売
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