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Amgen
May 07, 2026
Specialist Scientific IS Business Analyst
Amgen Thousand Oaks, CA
Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a...
re
Nov 09, 2024
Manager, Statistical Programming
regeneron Bernards, NJ
As an integral part of a study, the statistical programmer provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: Assist in providing mentorship in implementing and driving the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Design and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment. Support and/or lead programmer for...
re
Nov 09, 2024
Manager, Statistical Programming
regeneron United States
The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s). They will work with management and study team, plan and own the implementation and execution of programming project standard to support from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests. Be responsible for owning the programming aspect of a project and working with internal partnering functions, partners, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality. In this role, a typical day might include the following: Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming results in assigned projects and areas. Coordinate programming documentations and specifications for multiple studies following...
re
Nov 09, 2024
Associate Manager, Preclinical Operations
regeneron Tarrytown, NY
Preclinical Operations (PCO) is seeking a dynamic Associate Manager, Preclinical Operations  to join the team.  Using program management knowledge and experience in the drug development industry, the successful candidate would provide operational and Project Management support to Preclinical Development (PCD) and Drug Safety & Pharmacometrics (DSP) for multiple assigned projects .  The successful candidate would also provide guidance and input to cross-functional project teams to enable projects to drive to completion. This role has a 3-day onsite minimum requirement in Tarrytown, NY. Relocation can be provided. A typical day as an Associate Manager looks like: Facilitates development and alignment of  integrated PCD/DSP cross-functional project deliverables, plans, timelines and  resources,to align with the overall project plan throughout the project lifecycle from preclinical through commercialization. Ensures effective execution of project plan to...
re
Nov 09, 2024
Associate Director, Program Clinical Data Management Lead
regeneron Bernards, NJ
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...
re
Nov 09, 2024
Associate Director, Program Clinical Data Management Lead
regeneron Bernards, NJ
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...
re
Nov 09, 2024
Associate Director, Clinical Data Management Lead
regeneron Bernards, NJ
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...
re
Nov 09, 2024
Associate Director, Clinical Data Management Lead
regeneron Bernards, NJ
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...
re
Nov 09, 2024
Associate Director, Clinical Data Management Lead
regeneron Bernards, NJ
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks,...
re
Nov 09, 2024
Senior Statistical Programmer
regeneron Bernards, NJ
A senior statistical programmer provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: The incumbent assists in providing guidance in implementing and executing the programming and project standards. The evaluation and development of study  requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of...
re
Nov 09, 2024
Associate Director, Program Clinical Data Management Lead
regeneron United States
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...
re
Nov 09, 2024
Mgr Statistical Programming
regeneron United States
The Manager Statistical Programming provides timely support to the study team on all programming matters according to the project strategies. Provide project leadership and programming support for processing data from clinical studies. Provides guidance in implementing and performing the programming and project standards. Lead the programming aspect of a project, both internally or CROs, for all programming results from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. In this role, a typical day might include the following: Develop an expertise within a therapeutic area or standard tool. Work with minimal direction to perform, coordinate and be responsible for the preparation, execution, reporting and documentation of a project. Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements using Regeneron tools and methodologies and current...
re
Nov 09, 2024
Sr. Principal IT Engineer
regeneron United States
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are groundbreaking innovative ways to science, manufacturing, and commercialization, as well as redefining our understanding of health. The Regeneron Information Technologies team is seeking candidate for the Sr Principal Engineer of Secure SDLC Software Development position. This is a hands-on position that requires deep technical expertise in this Secure SDLC domain, the successful candidate will be responsible for the design, engineering, deployment, governance, and level 3 support of the Regeneron Secure Software Development Life Cycle (SSDLC) framework, and solutions. In this role typical day might include performing the following: Drive forward the development, improvement,...
re
Nov 09, 2024
Associate Director, Program Data Management Lead
regeneron Bernards, NJ
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...
re
Nov 09, 2024
Mgr Project Management
regeneron Armonk, NY
The Project Manager provides support for complex cross-functional strategic projects as directed by Senior Project Managers or Program Managers. The Project Manager will support driving and delivering results per charter goals, managing scope, schedule, quality, resources, risk and value/ benefit.  The Project Manager will also manage medium to small projects independently for the business or internal to the function with oversight by more seasoned Program/Project Managers or leadership. A Typical Day Might Look Like this: Plan, manage, execute and deliver a project through its lifecycle within the approved scope, schedule and budget  Secures acceptance and approval of deliverables and perceived value from the Project Lead and Stakeholders  Estimates and coordinates project resources  Maintains the Project Charter, schedule, issues log, budget and risk management plan Manages the risk register and the escalation of risks and issues. Partners with Change...
re
Nov 09, 2024
Associate Manager Drug Development Program Management
regeneron Tarrytown, NY
With guidance, an Associate Manager, Drug Development Program Management (DPM) uses program management knowledge and experience in the drug development industry to provide operational leadership and manage components of development program(s). You will contribute to the cross functional development team (Strategic Program Team) to develop strategic plans including goals, budgets, timelines and track the execution of these plans from preclinical through commercialization/lifecycle management.  This role has a 3-day onsite requirement in either Tarrytown, NY or Basking Ridge NJ. This role is not eligible to fully remote work. A typical day as an Associate Manager in DPM looks like: Project Planning and Execution: Assist in the development and maintenance of integrated project plans, timelines, and budgets for drug development programs. Plan, track and manage project milestones, dependencies and critical path through existing project management planning systems and...
re
Nov 09, 2024
Senior Director, Transformation Program Management
regeneron Armonk, NY
This is a hybrid position on-site 3 days per week in Armonk, NY or Basking Ridge, NJ and 2 days from home. A fully remote role is not possible for this position. The Senior Director, Transformation Program Management will play a vital role in the planning, execution and delivery of cross-functional and complex non-drug strategic and transformational initiatives for Global Development and other areas of Regeneron as requested. This role will collaborate closely with senior and executive leaders and stakeholders to drive the business transformation across the organization. The Senior Director Transformation Program Management communicates and collaborates with executive stakeholders and customers to ensure alignment and satisfaction. This role consults and negotiates with the Director Business Transformation Lead and Director Transformational Change & Engagement to translate business objectives into programs of work to be executed upon. This role requires a visionary leader...
re
Nov 09, 2024
Sr QA Validation Specialist (IT Infrastructure)
regeneron United States
The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory requirements and company standards.   As a Sr QA Validation Specialist (IT Infrastructure) typical day might include, but is not limited to, the following:  Analysing the results of testing and determines the acceptability of results against predetermined criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to...
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