研究開発・メディカルアフェアーズ統括本部Statistical Analyst

1ヶ月前

Hyogo Lilly Full time

We're looking for people who are determined to make life better for people around the world.

< 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

 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.

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

    • 【就業場所】 神戸本社 東京支社

    従事すべき業務の変更の範囲 :当社業務全般

    就業場所の変更の範囲 :将来のキャリアの一環として、神戸本社・東京支社・西神工場・ 海外オフィスでの勤務をする場合もありうる

    Business title: Statistician , Senior Statistician, Principal Statistician -GSS-J(CS)

    < 処遇>

    【給与】当社規定により優遇します

    【諸手当】住宅手当、通勤交通費など

    【昇給】有り

    【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。【勤務時間】8:45~17:30

    【時間外手当】"担当職"のみ支給

    【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

    【在宅勤務制度】有 【受動喫煙対策】あり 就業場所 全面禁煙

    【休日休暇】完全週休2日制(土・日曜日)、祝日、年末年始・夏期

    *年間休日125日、年次有給休暇、慶弔等

    【保険】雇用・労災・健康・厚生年金保険

    【福利厚生】住宅援助制度、借上社宅制度、リリーグループ補償制度(医療費・歯科医療費補助制度等)

    【定年制】有(60歳)

    【継続雇用制度】:有(65歳まで)

    【有給休暇】

    年途中で入社した社員に対する年次有給休暇は、次の入社月の区分に従い入社の翌月1日に付与さる。入社日にかかわらず、その年の12月31日をもって、勤続年数が1年経過したものとみなし、翌年1月1日に翌年度の年次有給休暇が付与される。

    入社月 1-6月 7月 8月 9月 10月 11月 12月

    付与日数

    【試用期間】 6か月間 試用期間中での賃金の違いはございません

    Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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