＜研究開発・ﾒﾃﾞｨｶﾙｱﾌｪｱｰｽﾞ統括本部＞Project Statistician/ Statistician , Senior Statistician, Principal Statistician /Kobe HQ・Tokyo

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

<職務内容>

The Project statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.

[Clinical Project Statistician]

Provide strong statistical leadership in the process of drug development.

[Real World Analytics Project Statistician]

Provide input and statistical leadership for post launch activities including Health technology assessment (HTA), real world evidence (RWE) research, post-market safety studies, medical affairs publications to maximize the value of our products in collaboration with cross-functional and cross-regional partners.

主な職責/Primary responsibilities

Statistical Trial Design and Analysis

[Clinical Project Statistician]

Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.

Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.

Collaborate with data management in the planning and implementation of data quality assurance plans.

Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.

Participate in peer-review work products from other statistical colleagues.

[Real World Analytics Project Statistician]

Lead statistical activities with the development of protocols, analysis plans and analysis execution and interpretation for RWE research and post-market safety studies.

Provide technical statistical leadership for network meta-analysis/indirect comparisons, economic modelling and dossier development for Health technology assessment (HTA).

Ensures high quality statistical support for projects through the oversight of external suppliers and provides input into outsourcing strategy and processes.

Influences cross-functional team members regarding appropriate research method.

Communication of Results and Inferences

Collaborate with team members to write reports and communicate results.

Assist with, or be responsible for, communicating study results via regulatory submissions,

manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.

Respond to regulatory queries and to interact with regulators.

Therapeutic Area Knowledge

Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

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

Basic Requirements:

• M.S. or Ph.D. in statistics or biostatistics

Other Information/Additional Preferences:

• Rich experiences in healthcare field as a statistician with science background such as mathematics or epidemiology.
• Statistical and methodological knowledge 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

<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 10 5 4 3 2 1 0

【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

【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

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