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| 部署・役職名 | Statistical Analyst（臨床統計）【担当/担当課長/専門課長】 |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
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. ◆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. ・Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements. ◆Use Communication Skillsets ・Collaborate with team members and/or global counterparts to deliver statistical results on time. ・Coordinate workers dedicated to preparing statistical datasets and outputs. ・Present any topics related to own responsibilities, such as new tools, methodologies, regulatory requirements, etc. ・Respond to regulatory queries and to interact with regulators. ・Reach out external parties to make environmental shaping happen. ◆Therapeutic Area Knowledge ・Understand disease states and related medical assessments for preparing appropriate definitions and/or specifications that fulfills statistical analysis objectives. ◆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. ◆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. 【勤務地】神戸本社、東京支社 ※左記いずれかのご希望をお知らせください。 ※スーパーフレックス、在宅勤務制度有り |
| 労働条件 |
【労働条件】詳細は面談の際にお伝えいたします（年収：600～1300万円目安） 賞与：年一回（個人業績結果及び会社業績結果に基づく業績変動賞与を翌年3月に支給する。） 諸手当：住宅手当、通勤交通費等 【受動喫煙対策】就業所内全面禁煙 【勤務時間】8 :45 ～17 :30 【在宅勤務制度】有 【清算制フレックス勤務】適応あり。（スーパーフレックス）フレキシブルタイム：5時～22時（昼休憩を除く）、1日の必要最低労働時間：4時間（半日休暇時は2時間）昼食休憩：12時～13時 |
| 応募資格 |
【必須（MUST）】 ・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. ・Good communication and presentation skills in both English and Japanese ・Statistical/methodological knowledge and computational skill in clinical development, epidemiology, or related field. ・Regulatory knowledge of clinical trial methodology and statistics. 【求める人物像】 ・Ability to build relationships with individuals and teams. |
| 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 | 2024/09/27 |
| 求人番号 | 3614881 |
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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