仕事内容<職務内容>
Provide strong statistical leadership in the process of drug development.
The statistical analyst provides strong leadership in the process of drug development, by preparing CDISC complied databases, statistical summary table/figures in accordance with a schedule. During the development of protocol designs, data analysis plans, and regulatory interactions, it is expected to collaborate with relevant study team members and provide assists from statistical analyst point of view.
主な職責/Primary responsibilities
Statistical Analysis Results Delivery
・Operate in collaboration with global counterparts to prepare CRT packages appropriately meet with regulatory requirements.
・Understand selecting statistical methods for data analysis, then prepare programing codes for delivering analysis datasets and outputs accordingly.
・Collaborate with data management in the planning and implementation of data quality assurance plans.
・Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements.
・Obtain project management skillset to coordinate delivering database and/or statistical outputs.
・Participate in peer-review work products from other statistical colleagues.
・Seek for any innovations towards more efficient working model realized.
Use Communication Skillsets
・sets and outputs accordingly.
・Collaborate with data management in the planning and implementation of data quality assurance plans.
・Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements.
・Obtain project management skillset to coordinate delivering database and/or statistical outputs.
・Participate in peer-review work products from other statistical colleagues.
・Seek for any innovations towards more efficient working model realized.
Therapeutic Area Knowledge
・sets and outputs accordingly.
・Collaborate with data management in the planning and implementation of data quality assurance plans.
・Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements.
・Obtain project management skillset to coordinate delivering database and/or statistical outputs.
・Participate in peer-review work products from other statistical colleagues.
・Seek for any innovations towards more efficient working model realized.
Statistical leadership and Teamwork
・Introduce and apply innovative methodology and tools to solve critical problems.
・Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
・Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.
経験・資格<必須経験/スキル・資格>
どちらかを満たす方
M.S. in statistics, biostatistics, or computer science, but not limited to. Any relevant certifications would be acceptable.
or
Rich experiences in healthcare field as a computational statistician with science background such as biology or epidemiology.
Statistical/methodological knowledge and computational skill in clinical development, epidemiology, or related field.
Regulatory knowledge of clinical trial methodology and statistics.
Ability to build relationships with individuals and teams.
Good communication and presentation skills in both English and Japanese
勤務地
想定年収
福利厚生・待遇
勤務条件【勤務時間】8：45～17：30
【清算制フレックス勤務】適応あり。フレキシブルタイム：5時～22時内で勤務。(ただし、一斉休憩を除く)1日の必要最低労働時間：4時間(半日休暇時は2時間)一斉休憩：12時～13時
完全週休2日制（土・日曜日）、祝日、クリスマス、年末年始・夏期※年間休日125日 年次有給休暇、慶弔等
6か月間
試用期間中での賃金の違いはございません
昇給年1回、賞与年3回
保険（雇用・労災・健康・厚生年金保険）
Recruiting No.
社名
事業内容
【東証プライム上場 財閥系 総合重機メーカー】 AI・データサイエンティスト（機械学習、深層学習、大規模言語モデル）
【AIを活用したデータ解析や情報管理のソリューション企業】 AI事業本部 ライフサイエンス分野でのAI研究
【東証プライム上場 医療機器メーカー】 製品開発部 新製品の仕様策定・要件定義等
多くの人が待ち望み、誰も作れなかった新薬を高度な技術で生産し、世界市場に届けます。
医師が安心して意見交換できる会員制サイト『MedPeer』。臨床の「集合知」が新しい価値を生み、ビジネス拡大中です。
「ODMメーカー」として、業界の中で独自の事業展開をしていこうとしています。
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