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Jobs list of Pharmaceutical & Data Management / Biostatistics

6 jobs
Showing 1-6 of search results
  • NEW
    Job number: Job-00235096 Posted: 2024-02-26

    Data Scientist

    Japanese multinational IVD maker
    5.5 - 9 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    Our client is a corporate group centered on outsourced clinical testing and the diagnostic reagents business.
    Responsibilities
    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
  • Job number: Job-00209423 Posted: 2024-02-14

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

    統計解析の経験ある方必見です
    10 - 15 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    Our client is developing and providing various medicines for an array of health concerns.
    Responsibilities
    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
  • Job number: Job-00244988 Posted: 2024-02-14

    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!
    6 - 10 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    Our client is a prime SI that provides comprehensive IT solutions.
    Responsibilities
    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
  • Job number: Job-00212456 Posted: 2023-07-19

    [Tokyo] Medical Information Specialist

    Fast Growing Global Co. & Remote Access
    5.5 - 8 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    Leading global CRO company
    We provide drug discovery, development, lifecycle management and laboratory services.
    Responsibilities
    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
  • Job number: Job-00204791 Posted: 2023-07-03

    Manager, Bio-Statistician

    Global Company
    10 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    This company is the world\'s leading pharmaceutical company.
    Responsibilities
    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
  • Job number: Job-00212457 Posted: 2023-06-15

    [Tokyo] Manager of Operations

    New Department & Management Role
    7 - 10 million yen Tokyo Pharmaceutical Data Management / Biostatistics

    Company overview
    Leading global CRO company
    We provide drug discovery, development, lifecycle management and laboratory services.
    Responsibilities
    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
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