20 development data coordinator jobs found

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing...

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Merck Job Description We aim to create workplace experiences that enable our people to be inspired to invent. Inside our organization, we provide workplace solutions that enable our people to do their very best work in safety. Outside our organization we ensure we protect the people around us, communities and the environment. Position Summary The Associate Director, Emergency Management, is responsible for providing strategic leadership, oversight, and management of the Security Command Center, Emergency Response Operations, and the General Emergency Management System (GEMS) Plan for the Elkton, VA facility. This role ensures the site's readiness to prevent, prepare for, respond to, and recover from emergencies while maintaining compliance with all applicable security, fire and life safety, and emergency preparedness regulations and standards. The position works closely with Plant Protection cross-functional teams to effectively and safely operate and maintain the...

Merck Job Description The Data Visualization Engineer will join the Data Insights and Visualization team to design, develop, and operate visual analytics and embedded tools that surface actionable, timely insights from network telemetry. You will be instrumental in integrating agentic AI agents and AIOps capabilities into dashboards and automation workflows so NCOS stakeholders can detect, triage, and resolve issues before they impact the business. Key responsibilities: Design and deliver end-to-end telemetry analytics and interactive dashboards that combine network flow, metrics, logs, traces, and business context to reduce time-to-insight and time-to-resolution. Identify, mine and normalize network data sources (e.g., NetFlow, SNMP, syslog, packet captures, telemetry APIs) and integrate them into real-time pipelines and visualization layers. Develop agentic AI agents and AIOps components that continuously analyze streaming telemetry to detect anomalies, infer...

Merck Job Description The Data Visualization Engineer will join the Data Insights and Visualization team to design, develop, and operate visual analytics and embedded tools that surface actionable, timely insights from network telemetry. You will be instrumental in integrating agentic AI agents and AIOps capabilities into dashboards and automation workflows so NCOS stakeholders can detect, triage, and resolve issues before they impact the business. Key responsibilities: Design and deliver end-to-end telemetry analytics and interactive dashboards that combine network flow, metrics, logs, traces, and business context to reduce time-to-insight and time-to-resolution. Identify, mine and normalize network data sources (e.g., NetFlow, SNMP, syslog, packet captures, telemetry APIs) and integrate them into real-time pipelines and visualization layers. Develop agentic AI agents and AIOps components that continuously analyze streaming telemetry to detect anomalies, infer...

Merck Job Description We aim to create workplace experiences that enable our people to be inspired to invent. Inside our organization, we provide workplace solutions that enable our people to do their very best work in safety. Outside our organization we ensure we protect the people around us, communities and the environment. Position Summary The Associate Director, Emergency Management, is responsible for providing strategic leadership, oversight, and management of the Security Command Center, Emergency Response Operations, and the General Emergency Management System (GEMS) Plan for the Elkton, VA facility. This role ensures the site's readiness to prevent, prepare for, respond to, and recover from emergencies while maintaining compliance with all applicable security, fire and life safety, and emergency preparedness regulations and standards. The position works closely with Plant Protection cross-functional teams to effectively and safely operate and maintain the...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director for its Policy and Research team to support policy and legislative/regulatory analysis related to drug pricing, including price-setting for medicines. The individual will be responsible for supporting PhRMA policy development and response to current and emerging technical issues related to drug pricing and price setting, including work shaping the implementation of the drug pricing provisions of the Inflation Reduction Act (IRA) and supporting defense against new price setting policies, such as foreign reference pricing. The Director’s specific focus will include issues pertaining to pricing, coding and payment for physician administered medicines covered by Medicare Part B. The Director will also support work related to the Centers for Medicare and Medicaid Innovation (CMMI). The Director will: Provide supportive expertise on the Medicare Part B drug pricing provisions of the...

Biogen Biogen's Decision & Quality Analytics Innovation (DQAI) team is part of Portfolio Leadership, Analytics & Insights (PLAI), which is under the Development department. The vision of the DQAI team is to deliver trusted insights that drive smarter decisions and measurable impact across the research, development and medical (RDM). We are seeking an experienced and highly motivated Associate Director of Data Management & Stewardship to join our team. This individual will take ownership of managing all aspects of our team's data - from acquisition and stewardship to governance and cross-functional alignment. The role will ensure that our data foundation is robust, well-governed, and positioned to enable advanced analytics, including AI/ML, simulation, etc. and ultimately support critical portfolio decision-making. Key Responsibilities Own the Data Foundation Manage the full lifecycle of portfolio and analytics data across research, development, and...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Biogen About This Role: As a Senior Pharmacovigilance (PV) Lead, you will provide strategic and operational PV/safety support for Biogen's West Coast Hub development programs, working closely with cross-functional colleagues. This Director level position is pivotal in overseeing global safety operations, ensuring high-quality pharmacovigilance deliverables, and offering expert guidance across the organization. You will manage internal and external PV resources, lead cross-functional safety governance, and serve as a subject matter expert for safety strategy across clinical development, regulatory filings, and post-marketing activities. This role is integral to the business structure, fostering collaboration and advancing the strategic safety objectives of the organization. What You'll Do: Manage internal PV personnel and external resources, including full oversight of all PV vendor activities to ensure operational excellence and compliance. Build (where applicable) and...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

Biogen About This Role The Director, Commercial Communications is responsible for leading the narrative for North America's performance, growth and transformation. This individual will be a strategic leader who develops a deep understanding of our commercial business in North America to drive compelling messaging and education for external and internal stakeholders. Working closely with senior leaders in Communications, Finance, Investor Relations, Operations and the North America leadership team, this role is responsible for the preparation and delivery of informative communications-including talking points, presentations, content and other materials-to prepare the President of North America to help build confidence that the organization is executing on its commitments. You will work with business leaders to synthesize the company's performance, market dynamics and customer insights, ensuring all external messaging is rigorously supported by data. This role will...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Research Director, Chemical Development, Associate Director, Chemical Development will apply direct manufacturing experience and chemical engineering tools & principles to support process design, scale up, technology transfer, control strategy verification, and production of small molecule drug substances and related compounds. The incumbent will provide actionable, technically sound recommendations that strengthen manufacturing robustness and ensure continuity of supply throughout the lifecycle of Nuvalent's products. The incumbent will work directly with the...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Research Director, Chemical Development, Associate Director, Chemical Development will apply direct manufacturing experience and chemical engineering tools & principles to support process design, scale up, technology transfer, control strategy verification, and production of small molecule drug substances and related compounds. The incumbent will provide actionable, technically sound recommendations that strengthen manufacturing robustness and ensure continuity of supply throughout the lifecycle of Nuvalent's products. The incumbent will work directly with the...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director for its Policy and Research team to support policy, as well as legislative and regulatory analysis, for Medicaid and the commercial health insurance market. The individual will be responsible for supporting PhRMA policy development and response to current and emerging public policy issues on coverage and access across the Medicaid and commercial health insurance markets, including state, insurer, and pharmacy benefit manager (PBM) actions. The Director will: Serve as a subject matter expert on public policy matters affecting Medicaid and the commercial health insurance markets with a focus on state, insurer, health plan, and PBM actions. Provide expertise on federal and state policies affecting coverage and access under the Medicaid program, including program eligibility, the Medicaid Drug Rebate Program (MDRP), approaches to management of prescription medicines through...