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製薬 × データマネジメント / 統計解析 の求人情報一覧

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  • NEW
    求人番号:Job-00270341 掲載日:2024-06-04

    データマネジメントプロジェクト責任者

    PJTの上流~下流までのデータマネジメント業務に携われる
    450 - 700 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は、医薬品開発支援事業など複数の事業領域において、業界をリードする企業です。
    業務内容
    医療機関等から収集したデータ(症例報告書)を予め設定した計画書に基づきデータクリーニングおよびコーディング等のデータ集計および加工する一連の業務を担っていただきます。入社後は、ご経験を踏まえて業務をお任せします。経験の浅い方は、徐々に担当できる業務の幅を広げ、データマネジメントの専門性を深めていただきます。
    業務内容:
    クライアント(依頼者)とスケジュールなどの協議、DM計画書作成
    EDC設計・構築(実際の構築は社内エンジニアチームが担当)
    社内の臨床開発部門・解析部門との連携や業務調整
    プロジェクトのスケジュール管理
    チェックリスト作成
    集計を伴うデータのチェック
    電子化するためのデータベースの準備
    派遣社員マネジメント
    ※データ入力は派遣社員が行います
    Momoka Yamashita
    Momoka Yamashita
    Pharma
  • NEW
    求人番号:Job-00270353 掲載日:2024-06-04

    統計解析プロジェクト責任者候補

    グローバルカンパニーで幅広い経験を積めるチャンス(治験から市販後まで)
    500 - 800 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は、医薬品開発支援事業など複数の事業領域において、業界をリードする企業です。
    業務内容
    医薬品・医療機器の開発(治験)から製造、販売後の調査における統計解析および、リアルワールドデータを用いた統計解析まで、総合的な医薬品・医療機器開発支援事業における統計解析業務を行います。薬医薬品・医療機器の有効性・安全性を統計学により適切に評価して、科学的根拠に基づくエビデンスを構築するために、高い統計解析の知見を活かしてプロジェクトを推進していただきます。入社後は、ご経験を踏まえた業務をお任せします。経験の浅い方は、社内外の充実した教育カリキュラムを通じてスキルを向上させ、徐々に担当できる業務の幅を広げ、統計解析の専門性を深めていただきます。
    業務内容:
    通常プロジェクト『解析計画の立案』 統計解析計画書や解析帳票レイアウトを規定するモックアップ作成
    『解析用データセット作成』 データマネジメント部門から受け取ったデータをSASで加工し、解析用データセット作成
    『CDISC対応』 CDISC関連ドキュメント作成、SDTM・ADaMデータセット作成
    『解析帳票作成』 統計解析計画書に基づき、様々な解析手法を用いてSASにより解析結果を出力

    上記以外で発生する業務『統計コンサルティング』 統計の専門知識を活かした様々なコンサルティング業務提案(症例数設計、プロトコールの統計パート作成、PMDA相談対応など)
    『薬物動態解析、母集団薬物動態解析(PPK)』  専門のソフトウェアを用いた薬物動態パラメータの算出、母集団薬物動態解析など
    『自社開発業務』 グループ会社にオーファンドラッグを扱う製薬会社をもつため、自社製品の開発または調査に統計解析担当として参加できる可能性があります。

    Momoka Yamashita
    Momoka Yamashita
    Pharma
  • 求人番号:Job-00265672 掲載日:2024-06-03

    Project Statistician

    Global mega-pharma with strong pipeline
    550 - 700 万円 関西 製薬 データマネジメント / 統計解析

    会社概要
    同社はアメリカに本拠地を置く、グローバル規模の医薬品・臨床研究の企業です。製薬を通して人々の健康や健やかな生活、長生きへの手助けをしています。世界中で生産性のある協定や提携を結び、規模を拡大させ製薬を低コストで開発を行い、世界で有数の製薬企業として成長しました。卓越した風土の中で誠意をもって取り組む社員が多く、更なる拡大に向けて邁進しています。
    業務内容
    Responsibilities:
    The Project statistician provides strong statistical leadership in the process of drug development, 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 also responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.

    Other Responsibilities Include But Not Limited To The Following
    Statistical Trial Design and Analysis
    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.

    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.
    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.
    Yui Osone
    Yui Osone
    Pharma
  • 求人番号:Job-00267735 掲載日:2024-05-22

    Pharmacoepidemiology Scientist

    Position at global mega pharma with very strong pipeline
    800 - 1400 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社はアメリカに本拠地を置く、グローバル規模の医薬品・臨床研究の企業です。製薬を通して人々の健康や健やかな生活、長生きへの手助けをしています。世界中で生産性のある協定や提携を結び、規模を拡大させ製薬を低コストで開発を行い、世界で有数の製薬企業として成長しました。卓越した風土の中で誠意をもって取り組む社員が多く、更なる拡大に向けて邁進しています。
    業務内容
    Responsible to lead safety observational studies as scientific lead and to deliver deliverables 
     Responsible as a study owner of regulatory mandatory safety studies under GPSP (Good Post-Marketing Surveillance Practice) 
     Demonstrate scientific leadership in safety observational studies, and ensure scientific level of study deliverables from pharmacoepidemiology perspective. 
    Define research questions, develop study design including statistical analysis plan based on research questions, evaluate and interpretate data (analyze in some cases) 
    Review and develop study report/publications. 
    Lead scientific discussion in cross functional team and in discussion with regulatory agency. 
    Collaborate effectively with global and Japan relevant functions and external partners (investigator, CROs) so as to deliver valuable evidence. 
    Support non-regulatory mandatory safety observational studies
     Provide pharmacoepidemiology expertise to support non-regulatory mandatory safety studies. 
    Engage in study protocol, study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders. 
    Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle
     Provide pharmacoepidemiology expertise to support compounds in development, new product launches, and existing marketed products. 
    Contribute to Japan Risk Management Plan (RMP) development, periodic report development. 
    Review and develop query response to regulatory authority. 
    Demonstrate knowledge of relevant global and local regulatory requirements and practices 
    Understand the roles & responsibilities of the EU Qualified person for Pharmacovigilance (QPPV) and support QPPV to enable to fulfill all QPPV legal responsibilities. 
    Contribute to organizational RWE capability development
      Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology. 
    Provide pharmacoepidemiology related trainings. 
    Support system/process development to enhance productivity or increase scientific quality. 
    Obtain up-to-date pharmacoepidemiology approach/knowledge 
     
    Yui Osone
    Yui Osone
    Pharma
  • 求人番号:Job-00212457 掲載日:2024-03-27

    [Tokyo] Manager of Operations

    New Department & Management Role
    700 - 1000 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は医薬品の開発過程を支援する各種の受託事業をおこなう日系企業です。
    業務内容
    Manages the day-to-day operations of the program team
    Supports staff members so that contracted services are provided in accordance with client and Medical Communications policies and procedures
    Trains and supervises Medical Communications support staff, experienced professionals and/or health care professionals on the program team
    Develops, coaches, and mentors’ employees
    Develops and maintains client relationships. Provides clinical expertise and guidance to clients and/or staff
    Develops employees and manages employee performance including performance appraisals, management and salary administration for direct reports. Monitors employee work. Handles employee relations issues, scheduling, and time record verification, recruiting and billable hours management
    Completes client reports, develops procedural documents, troubleshoots program issues, maintains program knowledge, and ensures compliance with company policies and procedures including SOP's, protocols, and FDA/COFEPRIS/ANVISA/ICH and other regulations
    Acts as liaison between the client, Medical Communications management and staff for issues such as workflow processes, available resources, and new initiatives affecting the program
    Handles all aspects of program training including providing training to staff members, developing curriculum, and documenting and maintaining training records and curriculum.
    Liaisons with the business development team, presents at PRM/ERMs, functions as a consultant or Medical Information professional to cover program services, such as, performing answering medical inquiries and documenting contacts, adverse events, and product complaints.
    Patrick Chang
    Patrick Chang
    Pharma
  • 求人番号:Job-00244988 掲載日:2024-02-29

    Data Scientist_Healthcare

    製薬企業の創薬支援のみにフォーカスいただけます!
    600 - 1000 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は総合ITソリューションを提供する、プライムSIです。
    業務内容
    リアルワールドデータ(リアルワールドエビデンス)を用いたお客様による薬剤疫学を活用したデータベース研究、マーケティング分析、医療技術評価、製品開発戦略、臨床試験デザイン、薬価算定 などを支援する業務。
    生物統計学の手法を用いて臨床試験・製造販売調査のデータを解析し、有効性および安全性を統計学的に検証する業務。 ※単なる解析業務の実施だけでなく IT/AIを活用した効率化・自動化するツール作成も含む。
    電子カルテ・レセプト・KDB・特定疾患レジストリなどの医療情報や、デジタルデバイスなどのヘルスケアデータのAI予測分析
    経験に応じて適切な業務を担当頂く。健康社会の実現に向けた法制度改革やデータ標準化等により今後ヘルスケアデータを活用する未来社会が見えてきており、それを先行して経験を積める業務領域となります。
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • 求人番号:Job-00235096 掲載日:2024-02-26

    Data Scientist

    Japanese multinational IVD maker
    550 - 900 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は受託臨床検査、検査薬事業を中心とする企業グループです。
    業務内容
    NGS等の高度遺伝子解析技術を用いた受託研究の実施
    受託研究の実施、解析パイプラインの開発、シーケンスデータ解析
    Linh Do
    Linh Do
    Medical Device
  • 求人番号:Job-00209423 掲載日:2024-02-14

    Manager (Principal Statistician), Statistical Modeling & Methodology, Statistics

    統計解析の経験ある方必見です
    1000 - 1500 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社はグローバル製薬会社です。
    業務内容
    Accountability:
    Provide statistical expertise in clinical development programs, development strategy, study design, data analysis and interpretation of results for clinical trials;
    Contribute to develop clinical development programs, development strategy and study design, in terms of statistical viewpoint, based on advanced TA/DA knowledge.
    Support broad implementation of innovative statistical approaches across the development portfolio.
    Support development and implementation of innovative approaches, participating in their hands‐on implementation through direct interactions with statisticians. This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write‐up.
    Participate in training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up‐to‐date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model‐based methods, etc.
    Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs.
    May engage in external collaborations within professional associations, participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals
    Identify opportunities for innovation; interact directly with statisticians and other “Quantitative Sciences” scientists (including global) for early identification of opportunities for innovative approaches.
    Contribute people development through coaching and advices with line managers in Biostatistics dept.
    Decision Making:
    Proposal statistical modeling approach to meet requirement and/or to solve issues for clinical development program.
    Influence:
    Facilitate strategic & data‐oriented (quantitative) discussion by utilizing statistical thinking such as modeling & simulation approach
    Provide statistical expertise to develop persuasive/logical data interpretation for regulatory approvals in timely manner.
    Implement “state‐of‐the‐art” statistical strategies and advanced methodology
    Lead the implementation of modeling & simulation approaches for development programs in Japan R&D through cross functional collaboration not only in Japan R&D but also global QS.

    Interface:
    Internal; J‐CoT (Japan Compound Team), QS‐J Matrix team, Group managers in Biostatistics dept, Statisticians including Statistical Modeling & Methodology (SMM) in SDS of global QS for projects assigned
     External; PMDA, Academia related to TA/DA assigned, Professional societies
    Patrick Chang
    Patrick Chang
    Pharma
  • 求人番号:Job-00212456 掲載日:2023-07-19

    [Tokyo] Medical Information Specialist

    Fast Growing Global Co. & Remote Access
    550 - 800 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は医薬品の開発過程を支援する各種の受託事業をおこなう日系企業です。
    業務内容
    Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support.
    Analyzes caller’s questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.
    Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.
    Maintains thorough knowledge of project and corporate policies and procedures including client products, SOPs, protocols, GCPs, and applicable regulatory requirements.
    Works closely with internal and external client contacts (up to and including members of client management) to resolve complex inquiries. As needed, researches medical literature and drafts responses for such inquiries.
    Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
    Learns to use professional concepts
    Apply company policies and procedures to resolve routine issues.
    Patrick Chang
    Patrick Chang
    Pharma
  • 求人番号:Job-00204791 掲載日:2023-07-03

    Manager, Bio-Statistician

    Global Company
    1000 - 1300 万円 東京 製薬 データマネジメント / 統計解析

    会社概要
    同社は医療用医薬品を研究・開発・製造・販売しています。
    業務内容
    Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
    Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
    Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
    Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.
    Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.
    Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
    Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.
    Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
    Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.
    Communicate and collaborate with global statisticians on assigned projects.
    Provide a strong statistical presence in regulatory and professional circles.
    Participate in research on statistical methodology and its applications to clinical trials/PMS.
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
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