43 jobs found in Newark, NJ

Job Description The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, 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 deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence,...

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...

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, 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 deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect,...

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, 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 deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect,...

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...

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...

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...

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...

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,...

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...

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...

The Associate Director, Systems Management is responsible for the strategic oversight and day-to-day management of systems that support the delivery of regulated documentation to business stakeholders. This role involves maintaining the electronic Document Management System (EDMS), acting as the Business Process Owner (BPO) for the EDMS workstream and workflows for Global Development, and collaborating with various departments to ensure the smooth operation and continuous improvement of these systems.   This role will lead the identification of EDMS data for reporting, analysis, and integration with other P&P software. In this role, a typical day might include: Strategic System Oversight and Day-to-Day Management: Provide strategic direction and oversight for systems that support the delivery of regulated documentation. Monitor system performance and address any issues that arise to minimize downtime and ensure continuous availability. Electronic Document...

The Senior Statistical Programmer provides support to the lead programmer and study team on all programming activities according to the study requirements and the timelines. This role contributes to studies in various therapeutical areas and all clinical trial phases. The incumbent implements and executes the programming and project standard under minimal supervision of the lead programmer and manager to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Maintains programming documentations such as study tracker, code, logs, and outputs in a regulated environment.   In this role, a typical day might include the following:    Provide programming support within multiple studies/projects in various study activities with timely and high-quality programming deliverables in assigned tasks and projects   Demonstrate company values by demonstrating excellence, competence,...

The Regeneron Genetics Center IT group seeks a Technical Lead for their Application Development team.  You will be responsible for providing technical leadership and oversight of a growing portfolio of solutions that empower our scientists’ research and discovery. This is a hands-on technical position with opportunities to speak to internal clients and manage work end to end. As a Technical Lead, a typical day might include: Developing solutions across the entire stack from web applications to cloud based APIs and services using JavaScript and AWS services. Engaging with internal clients to understand use cases and gather feedback. Managing technical work and timelines. Prioritizing and completing multiple initiatives in an agile environment. Coordinating cloud based (AWS) infrastructure with DevOps team. Keeping informed of new and emerging technologies to incorporate into our technical stack. Ensuring alignment to architecture guidelines and...

The Genome Informatics and Data Engineering team is looking for a passionate Lead Cloud DevOps Engineer with strong technical ability, communication, and collaboration skills. As the Lead Cloud DevOps Engineer, you will be responsible for managing AWS platform, implementation & management of solutions on AWS, from the ground up, to deliver highly scalable services. You will work with stakeholders, rest of the DevOps team, and subject matter experts to build and implement cloud platform solutions. Key focus areas include: Creating & managing containerized applications Building & optimizing CI/CD pipelines and enabling automated deployment of solutions on AWS Cloud with code quality and security testing Support core AWS services – S3, EC2, ECS, EFS, IAM, Lambda, RDS, Redshift, Cloud Formation and develop python & bash scripts for automating routine operations Good to have: Understanding of Data & Analytics. Knowledge on Slurm. Knowledge on WDL....

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...

We are seeking a Sr. Application Developer who can help develop and maintain applications to analyze and interpret millions of genotyped and sequenced human samples, and ensuring we deliver high quality and flexible tools to help scientists perform large scale genome-wide analyses. To enable the Regeneron Genetics Center to generate the knowledge necessary for delivering better medicines to patients, we must empower our scientists to efficiently generate and interact with results derived from millions of sequenced individuals. A proven track record of implementing scalable software tools in a cloud-based computing environment (i.e. AWS, DNAnexus, GCP) is essential for this role. As a Sr. Application Developer, a typical day may include: Implement new features to existing applications to fit users’ needs based on shifting state-of-the-art genetic analysis methods. Modernize and optimize existing applications to improve performance. Develop new applications and...

In Research and Pre-clinical Development IT, we deliver complex enterprise systems to help Research Scientists at Regeneron solve their toughest business problems. We bring together multi-disciplinary, highly skilled technical teams to deliver high-quality system solutions and services that deliver business value.   The Sr Principal IT Data Analyst (Data Solution Partner) with rich experience building Data Centric Solutions is a key role on the team, enabling science by leading and contributing to full software lifecycle; architecture, design, implementation, testing and deployment of Scientific Data Applications that add demonstrable value and impact to the scientific operations of Research & Pre-clinical Development (R&pD) functions at Regeneron.  You will be an integral team member to leverage our data platform, working closely with other team members as well as our scientists to organize/manage/transform our biology data in a way to enable our scientists to gain...

The Manager, Scientific Writing Operations supports and works closely with the Scientific Writing Operations Lead to support and assist with SW resource (capacity) management and development of the outsourcing strategy. In this exciting role, you will work with outsourcing vendors to facilitate contract development and implementation, while also onboarding/off-boarding activities while also supervising external consultants at times. A Typical Day in the Role Might Look Like: Screens and supervises external consultants Assists with contractor/vendor selection, initiation, and implementation of collaborations  Serves as point of contact with vendors for contracting and financial aspects of external engagements  Identifies training needs, monitors adherence to document processes, and provides support for external personnel Collaborates with Procurement, Finance, and Business Operations to help manage contracting, budgeting and spending for Scientific Writing Manages...

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...