Jobs list of Pharmaceutical & Data Management / Biostatistics

Associate Director, Data Management

TOP CRO

10 - 17 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: Our Client clinical is a contract research organization.
Responsibilities: Responsible for development and maintenance of following Data Management documents:Database Definition Document;
Data Entry Instructions;
Case Report Form Transmittal and Query Resolution Procedures;
External Database Import Specifications;
Data Management Guidelines;
Edit Check Specifications.

Oversight of following Data Management activities:Meet project timelines for all Data Management activities;
Patient Case Report Form and data query filing procedures;
Coordinate communication with external database providers for data transfers;
Coordination of clinical coding procedures and dictionary transfers;
Coordinate overall Data Management by serving as primary contact for Sponsor, external data providers, and all project team members.

May directly supervise Data Coordinators and Data Assistants

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

Pharmacoepidemiology Scientist

Tokyo based

8 - 14 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: Our client is one of the top medicine and Clinical Research companies worldwide.
Responsibilities: 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

SAS Programmer

Global CRO

7 - 10 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: Our Client clinical is a contract research organization.
Responsibilities: Using SAS, program, validate and maintain mapped database
Program edit checks for external data
Coordinate communication and issues with Data Management regarding database specifications and data transfers

Senior Statistical Programmer

Osaka location avail.

8 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: Our client is one of the world’s largest and most comprehensive drug development services companies.
Responsibilities: Job Primary Functions
Perform the role of the Lead Statistical Programmer
Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget,
meeting timelines, maximizing quality, interaction with other departments and the client, etc.Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs
Develop specifications for SDTMs and ADaM datasets
Review SAPs and TFL shells from a programming perspective for studies
Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
Present and share knowledge at department meetings
Respond to QA and client audits, and support qualification audits
Identify processes within programming that will increase productivity, quality and efficiency

[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.

Manager/Sr. Manager-Commercial Analytics

rich pipeline

8 - 12 million yen Kansai Pharmaceutical Data Management / Biostatistics

Company overview: Our client is one of the top medicine and Clinical Research companies worldwide.
Responsibilities: Partner with Japan commercial business teams to identify, scope, and execute analytics efforts that answer business questions, solve business needs, and drive business value
Maintain a broad understanding of the pharmaceutical business and be fully engaged with business teams, bringing an objective voice to the table, facilitating decisions grounded in data
Collaborate with other analytics team members to review and provide feedback on the analytics being conducted, and be willing to seek feedback from other team members about your own work
Stay current with respect to statistical/mathematical/informatics modeling methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected
Collaborate with internal and external partners to design, develop and deploy enterprise-level analytics capabilities/solutions
Enable cutting edge innovation in an area of data science such as machine learning, optimization, forecasting, or natural language processing
Serve as a bridge between Global Advanced Analytics & Data Sciences Team and Japan to enable shared learnings around capability building, new methodologies, and analytics results

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。

Statistical Scientist, Japan

global biotech

8 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: Our Client is a bio pharmaceutical company.
Responsibilities: Support development of components (CSR, CTD, CDISC, e-Data, DSUR) for submission to PMDA and interact with global and local team
Perform quality control of the key e-data and CDISC deliverables
Support Biostatistics interactions with PMDA as part of the response/inspection team.
Provide Biostatistics support (global studies including Japan, Japan standalone studies, PMS) in study data collection, data analysis, reporting, and submission preparation in close collaboration with global DM and Statistical Programming
Conduct ad hoc statistical analysis, including surveys utilizing Medical Information Databases (per PMDA requirement)
Be accountable for timely completion and quality of the statistical analysis plan
Collaborate with, direct or monitor programmers and/or statistical teams under supervision.
Perform statistical research or assist in evaluating statistical methodology related to drug development
Implement sound statistical methods related to drug development
Be responsible for result accuracy in study report and regulatory submission documents including archiving documents

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

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.

[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.

RWDプロジェクトマネージャー

【東京】希少性の高い医療データ / RWD

9 - 12 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: 同社は病院・救急隊向け急性期医療データシステムの開発・提供をしています。
Responsibilities: ■募集背景：弊社は大規模病院の救急外来向けに医療データプラットフォームを提供しており、全国47施設にて稼働（全て400床以上の急性期病院）、リリースから5年で大学病院の救命救急センターにおけるシェアは約30%に至ります。
また、この医療機関ネットワークを活用して、各施設にDPCデータ、検査データ、電子カルテデータ等を統合したデータプラットフォームを構築し、製薬企業向けにRWD解析サービスなどの医療データ事業を推進しています。
今回は、2022年から本格始動したRWD解析サービスの急成長による人員募集です。当初の計画を超えてサービスの導入が進んだため、より事業を成長させるためメディカル領域のプロフェッショナル人材を募集します。 ■お任せしたいミッション：製薬企業に対するRWD解析サービスの各プロジェクトをリードしていただきます。チームには臨床経験豊富な医師複数名やコンサル出身メンバー、データサイエンティストがアサインされ、一つの案件に対してプロジェクト提案〜デリバリーまでを一気通貫して行っています。MAやMSLを始め、その他周辺領域の経験を活かし、それぞれの案件におけるプロジェクト実行計画、研究デザイン、関係病院を巻き込んだ共同研究の推進、データ解析・取りまとめを行っていただきます。 ■本ポジションの特徴、醍醐味：①希少性の高いデータを扱う先駆的な経験現在、国内市場ではレセプトやDPC以外の商用利用可能な構造化データベースは殆ど存在せず、データ活用の幅も限定的です。一方で弊社は自社システムを大病院に広く提供しているため、難病やがん、急性期重症疾患などの集積する病院の、網羅的な検査値・バイタルサイン・医師の臨床診断名・基礎疾患や常用薬情報など他にはない医療データを扱うことが出来、RWD利活用における先駆者として稀有な経験をすることが出来ます。 ②急成長中の新規事業医療データ事業は2021年に立ち上げた新規事業です。とりわけRWD解析サービスに関しては2022年夏から本格始動し、半年足らずですでに複数の企業へのサービス提供が開始しています。少数精鋭で各分野のプロフェッショナルが集まっているため裁量は大きく、プロジェクトの一担当者に留まらず、事業をより成長させるための企画提案も行っていただけます。 ③急性期”だけ”でない幅広いカバレッジ弊社は救急医療プラットフォームを提供していますが、顧客医療機関では難病やがんのデータも多々扱っています。すなわち、扱う領域は「急性期」だけではなく、「がん」や「難病」など全診療科です。弊社のシステム導入先は大学病院を始めとする地域の中核病院であり、救命救急センター・がん診療連携拠点病院・難病診療連携拠点病院が多数含まれます。これらの標準化データベースにより、既存のデータセットでは扱えなかった疾患の明確なカバレッジを有したデータベースで、革新的な研究に取り組むことが可能となります。

Jobs list of Pharmaceutical & Data Management / Biostatistics

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