Jobs at Daiichi Sankyo
2,115 open positions
Senior Analyst, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 25, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Responsibilities include: support developing, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standards, develop/validate sample programs to generate standard ADaM dataset and TLFs, and develop and maintain programming macros to effectively support internal data review and data surveillance. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Bachelor's Degree preferred Experience Qualifications - 4 or More Years Bachelor's degree with (or Master's degree with minimum 2 years) proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred - Advanced working knowledge of SAS programming language used in clinical trials programming preferred - Advanced working knowledge of CDISC ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Working knowledge of CDISC SDTM preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred - Knowledge of drug development preferred - Experience in regulatory submission and support preferred - Solid background in applied statistics preferred - Solid knowledge of new, advanced statistical methods using SAS and R is a plus preferred - Knowledge in database structures and set-up preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Responsivities include: create analysis dataset (including specifications) and TLFs to prepare submission, respond to agencies' questions, perform ad-hoc analysis requested by clinical team, provide programming supports in potential Oncology Drug Advisory Committee (ODAC) - Support programming project lead to oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning as the backup of the programming project lead, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, maintain all required study programming documentation required for Trial Master File (TMF) - Support building up DSI compound specific programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data surveillance, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity - Provide programming supports for submission and help submission team in quick turnaround in exploratory analysis and response to regulatory agencies. Responsibilities - Perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies and integrated analysis, and expedite the preparation of regulatory submissions. Summary The purpose of this job is to support quality assurance of statistical vendor deliverables, including performing programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensuring deliverable quality, and helping to expedite the preparation of regulatory submission. It will also to support statistical analysis during submissions and post-submission regulatory response period by independently developing and/or validating analysis datasets, and TLFs. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Director, Global Project Management and Leadership
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 24, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Provide feedback, coaching support, and recognition to direct reports including objective setting, mid-year assessment, year-end review. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Attract, hire, retain, coach, develop and promote talent individuals to exceed expectations in delivering on company business objectives. Collaborate with global, cross-functional project teams to define project scope, deliverables, responsibilities and timelines. Experience Qualifications 10 or More Years relevant project and change management, process improvement, business analysis or consulting experience required.Prior work experience as a top tier management consultant, project and change manager or similar role in pharmaceutical drug development desirable.Project Management, Change Management or Process improvement qualification, certification or diploma preferred.Scientific background desirable preferredKnowledge of pharmaceutical industry/drug development preferred. Identify the needs and define the content required to support change management, communications and training needs (e.g., stakeholder analysis, training requirements, stakeholder communications) to ensure successful implementation within the business. Foster a positive work environment where different work styles and approaches, that still meet individual and team objectives, are sought out and encouraged. Education Qualifications (from an accredited college or university) Bachelor's degree in science, engineering or business. Coach and support individual development of team.
Director, Trial Feasibility, Recruitment and Retention
Company: Daiichi Sankyo
Location: Other US Location
Posted Nov 22, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. preferred - Ability to demonstrate, interpret, explain, represent, and drive unbiased data-driven insights into clinical trial operational planning. preferred - Expertise in principles driving country/site identification, feasibility and selection strategies. CROs, specialty Vendors) and internal to Daiichi Sankyo (e.g. Regional Site Engagement Managers) are well defined, clear and aligned -Oversee, train and mentor employee and/or contractor-based staff/analysts to support the overall end to end feasibility processes and oversight, and timely and consistent data and insight package development. Education Qualifications (from an accredited college or university) - Bachelor's Degree required Experience Qualifications - 7 or More Years 7 + years global clinical operations experience in study feasibility, and/or study design optimization. preferred - Proven track record of providing feasibility related services and value to organization(s) preferred - Demonstrated success in working cross-functionally in a global matrix organization preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. - People management -Ensure feasibility related roles and responsibilities within external partners (e.g. required - Proficiency with software models and database structures. -Incorporate data analysis (e.g., local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and establish a geographic country footprint and proposed sites for participation in a clinical study.
Associate Director, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 25, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Responsibilities include: contribute to CRF and SDTM standard development, develop, implement, and maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary programming macros or tools to effectively support all programming needs. Responsibilities include: continue assessing DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Responsibilities include: develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting - Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 10 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred - 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred - Previous experience supporting SAS macro and/or system utility development preferred - Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred - Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred - Solid background in applied statistics preferred - Solid knowledge of new advanced statistical methods using SAS and R preferred - Advanced knowledge in database structures and set-up preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool implementation and maintenance - Evaluate, assess and enhance DSI computing environment system. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity. - Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities - Supporting project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision.
Manager, Data Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 17, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. or 4 years with a M.S. of SAS and clinical programming experience in the biotech/pharmaceutical/CRO industry is requiredExceptional understanding of clinical data and generating exceptional listingsHands on knowledge of Spotfire or J-Review is a plusPrior experience working with vendors and stakeholdersGood communication skills and an ability to work cross-functionally is required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Responsibilities Perform all programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/QA of CDISC, SDTM domain output in accordance with SOPs, SOIs, and guidance documents.Manage external vendors and ensure accurate and high-quality deliverables.Ensure documentation and consistent maintenance of code, logs and output within a regulated computing environment.Create and maintain specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.Develop, implement and maintain SAS programming standards and performs quality checks.Review annotated case report forms and database structures.Develop reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient profiles on an ad hoc basis to support the Biostatistics, Data Management, and clinical teams.Mentor and train other associates within Data Management, as necessary.Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.Review deliverables before transfer to either internal or external clients ensuring quality. Education Qualifications (from an accredited college or university) Bachelor's Degree requiredMaster's Degree preferred Experience Qualifications Minimum of 6 years with a B.S. These include developing and validating SAS programs for clinical trials. Summary The Manager, Data Programming is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required for clinical trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Manager, Data Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Oct 26, 2023
Daiichi Sankyo Group, a global pharmaceutical company with over 100 years of experience, is dedicated to creating innovative therapies for diverse medical needs. The company is primarily focused on oncology, rare diseases, and immune disorders. The position in question manages end-to-end data management services for projects, collaborating with CROs and vendors to ensure high-quality deliverables. The role requires a Master's or Bachelor's degree in life sciences, 4+ years of data management experience, and expertise in clinical operations and regulatory requirements. The position involves leadership, project management, functional expertise, and operational efficiency.
Associate Director, Global HR Communications and Change Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Dec 04, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Education Qualifications (from an accredited college or university) - Bachelor's degree in science, business, liberal arts or related field of study required - Master's Degree preferred Experience Qualifications - 10 or More Years Experience in corporate communication, public relations, or related roles required - Experience supporting (or working in) human resources or related function with communications (e.g., employee engagement and change management, employer branding, culture, people strategy, etc.) preferred - Healthcare communications experience preferred - Relevant change management experience, demonstrating subject matter expertise of change communications and a winning track record of successful outcomes of strategic initiatives required - Proven track record of developing and executing successful communication strategies for a global organization required - Exceptional written and verbal communication skills, with the ability to refine complex concepts into clear, compelling messages required - Strong relationship skills, and the ability to manage various internal and external stakeholders required - Native-level English (required) and native-level or fluent Japanese preferred Physical Requirements Flexibility in working hours for meetings with global teams across different time zones. - Create communications tactics and messages to all employees and beyond, including presentation materials and talking points for internal / external meetings, written communications, video messages, etc. - Ensure all change communications are streamlined and aligned with the Global HR Vision and strategy. - Lead and oversee the creation of various global communication materials. Occasional travel for company meetings and domestic/international trips. - Design and execute change communication plans, constantly evaluating their effectiveness and making improvements as needed. - Partner across stakeholders to integrate and manage all communications from initiatives across HR.
Associate Director, US Customer Insights
Company: Daiichi Sankyo
Location: Other US Location
Posted Dec 04, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. - Mentor, train and develop peers and other team members in the appropriate methods of marketing research, business analytics, competitive intelligence, scenario planning, project management, data analysis, and developing recommendations. Education Qualifications (from an accredited college or university) - Bachelor's Degree required - Advanced degree in relevant business area preferred - MBA preferred Experience Qualifications - 7 or More Years overall related experience required - 7 or More Years Expertise in primary research methodologies and working knowledge of secondary data sources required - 7 or More Years Expertise in conducting primary market research studies, and selecting, collaborating with, and managing market research vendors required - Demonstrated analytical skills required - New product launch experience preferred - experience in Oncology preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Maintain high level of proficiency and understanding of currently available data sources, analytic techniques and Market Research agency capabilities to ensure the appropriate selection of agencies, products, and services that provide Daiichi Sankyo with optimal value for our budget investment. Work collaboratively with analytics teams (Business Intelligence, Forecasting, Market Planning, Sales Ops), as well as extended business partners (Brand teams, Access Strategy, Medical Affairs, and Finance), to inform key business decisions. - Develop functional excellence by identifying and demonstrating "best practices" in market research and business analytics, incorporating learnings from across the industry. Responsibilities - Design and execute primary marketing research studies to generate insights informing strategic efforts, price/access strategy, LCM, forecasting, branding, and marketing mix.Prepare presentations, deliver research findings, and make strategic recommendations that maximize the long term value of the brand and ensure that it achieves annual sales goals. - Develop, coordinate and implement analysis and integration of secondary research data into actionable recommendations for strategic and tactical plans. Develop strong working relationships with senior business partners (Brand teams, Global teams, Co-promote partners, etc.) Identify and attend appropriate medical meetings, incorporate key learnings from papers, presentations and competitive intelligence and identify key clinical and medical findings that may impact branded products and development of Daiichi Sankyo pipeline compounds.
Manager, EDC Database Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Oct 25, 2023
Daiichi Sankyo Group, a global pharmaceutical company with over 100 years of experience, is dedicated to creating innovative therapies for diverse medical needs. The company is primarily focused on oncology, rare diseases, and immune disorders. The Manager, EDC Database Programming, a member of the Biostatistics and Data Management team, is responsible for overseeing, guiding, and designing study build activities for all clinical studies Electronic Data Capture systems. This role involves managing study build deliverables, ensuring high-quality, consistent, and adherence to eCRF specifications. The individual will also engage in the governance, management, and advancement of DS Global Library Standards, collaborating with various stakeholders.
Associate Director, CSPV Risk Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 24, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. - Risk Management Compliance Inspection Readiness Champion. Lead and/manage RMP initiatives and activities related to risk management planning, risk management sciences, and risk management tools and resources. Serve a key support during Risk Management Inspections. Keeps management aware of any gaps in risk management planning, creation, and execution - Lead/Manage RMP initiatives. Serve as member of Risk Management office to ensure risk management activities allow for effective preparation for inspections/audits. - Risk Management Champion: Serves as member of the Risk Management office to provide knowledge of regulator and industry trends related to risk management. May draft and/or propose changes to SOPs/SOIs related to risk management. Education Qualifications (from an accredited college or university) - Bachelor's Degree In Healthcare Related Field required - PharmD preferred - PhD preferred Experience Qualifications - 4 or More Years of relevant experience in risk management and project management required Travel Ability to travel up to 20% Domestic and International Travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 6) Guides and supports with the alignment of RMPs, labels in key regions (US, EU, Japan) and periodic reports.
Director, Global Project Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 16, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Maintains project status in the project management information systems. preferredProven track record as a leader/influencerDirect people management experience preferred Licenses and Certifications Project Management Professional (PMP) Certification and/or training in project management preferred. Ensures Project Team awareness of the Global Development ProcessesActively contributes to progressing the GPM&L department as an SME or leader of a departmental initiative. Education Qualifications (from an accredited college or university) Bachelor's Degree requiredAdvanced degree preferred (i.e., MS, MBA or PhD) in a scientific discipline with additional relevant experience preferred Experience Qualifications 10 or More Years4 or More Years in a PM or related role in a biotech or pharmaceutical company preferredDemonstrated success as a project manager/leader in planning and executing strategies for global drug development, commercialization and life cycle management. Prepares scope change proposals and stage gate proposals for formal presentation to senior management.Is comfortable working independently within a matrix environment and can coach, influence and mentor more junior PMs, team members and project team stakeholders.Identifies and implements PM best practices for the broader GPM&L organization. Develops and maintains a high performing team. Can generate critical path analyses and support scenario planning. This position will report to the Sr Director, Group Leader, GPM&L or the Executive Director, US Head GPM&L.
Associate Director, Competitive Intelligence
Company: Daiichi Sankyo
Location: Other US Location
Posted Sep 20, 2023
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Education Qualifications (from an accredited college or university) - Bachelor's Degree required - MBA or other Advanced degree preferred Experience Qualifications - 7 or More Years overall related experience required - 4 or More Years of pharmaceutical experience, of which at least 3-5 years in CI, marketing research or business analytics within a Global Team or US Region required required - Prelaunch or In-line market research experience preferred - Experience in multiple regions preferred - Experience with Japan preferred - Superior analytical skills are required with an understanding of a broad range of CI & marketing research methodologies required - Expertise with CI and methodologies for all lifecycle phases required - Proficiency with global & regional CI vendors necessary to assess clinical and commercial status and end to end overall strategy of competitive assets required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. He/she is accountable for helping to 1) inform the current process, 2) building new capabilities, and 3) co-leading initiatives related to competitive intelligence. Responsibilities - Working under the direction of the Senior Director CI, he/she will collaborate on the Brand Strategic Plan for multiple assets, provide directly and through the team a CI plan to support market and clinical insights across the oncology portfolio - Assist in securing the execution of the CI plan through robust methodology in a timely manner and thorough selection of the subject matter expert vendors - Ensure consistency and create synergies across DS products by maintaining the same framework of key deliverables - Foster strategic partnership with all internal and external CI resources (DS Medical Affairs, DS Scientific Library and Alliance Partner) - Be an influential voice as a business partner for each Brand Lead regarding CI for their respective Brands - Develop and assist in maintaining a repository of market clinical knowledge for each tumor type that will become a reference document for Brand teams and that will feed the tumor strategic document - Interface with regions to share outputs of competitive intelligence as well as to get an integrated plan with regions to avoid duplication - Beyond data collection, articulate key competitor's strategy to inform Brand leads on new threats and opportunities - Help to coordinate the communication of competitive intelligence in an actionable manner - Operate Competitive Intelligence within Daiichi Sankyo SOPs and highest standard of professional conduct Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. In addition to the strong business relationship with global stakeholders, he/she must build trustworthy business relationships with external partners and regional stakeholders. His/her leadership enables the team to develop a comprehensive competitive intelligence plan to support Commercial, Medical and Clinical R&D functions. Summary The Associate Director, Competitive Intelligence works closely under the direction of the Senior Director, CI and is accountable for insight generation at the global level for all oncology assets within Daiichi Sankyo. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. The incumbent enables relevant and prioritized insights to be generated and cascaded across the organization at the highest standard in a timely manner. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.