22 senior data steward jobs found

Biogen About This Role: As the Director of Device Clinical Affairs, you will lead the strategic and operational efforts for clinical programs centered around implantable medical devices. Your role is pivotal in ensuring that studies are conducted to the highest scientific, regulatory, and quality standards. You will oversee complex, multiphase clinical development strategies, from startup to closeout, guiding decision-making that influences program direction and regulatory success. Collaborating with teams across Regulatory, Quality, Engineering, Medical Affairs, Marketing, and external partners, you will provide critical clinical evidence and insights for regulatory submissions, labeling, human factors studies, and verification/validation activities. Your expertise will be key in bringing innovative medical device solutions to market, enhancing patient care and outcomes. What You'll Do: Lead the execution of device clinical studies, ensuring compliance with...

Biogen About This Role The Clinical Trial Transparency (CTT) Specialist supports delivery of CTT activities for assigned studies, helping to manage the compliant disclosure of clinical trial registration and results information on public registries and ensuring meaningful trial information is shared with the public. The CTT Specialist is a contributor for one or more areas of the CTT function such as process, technology, and vendor oversight. The CTT Specialist contributes to improving the quality, efficiency, and overall performance of one or more CTT processes to include areas such as planning activity and compliance tracking, protocol registration, tabulated results, and local country disclosure. The Specialist supports maintenance of standard operating procedures and may assist with training. The CTT Specialist has a basic understanding of business needs and information/data flow to contribute to optimization of technological solutions. In support of vendor oversight,...

Biogen About This Role: As the Senior Director of Device Development, you will lead the charge in selecting, developing, and managing the lifecycle of platform and innovative non-implantable drug delivery devices, focusing on prefilled syringes, autoinjectors, and on-body delivery systems and combination product development. Joining the Product Delivery Solutions team, your role is crucial in advancing technology from conception through commercialization, ensuring these solutions enhance patient experiences and clinical performance. You will shape the combination product device portfolio strategy, influencing enterprise investment decisions and positioning Biogen competitively in the subcutaneous and home-use landscape. Reporting to this role is a multidisciplinary engineering organization, which you will oversee to drive iterative design, risk reduction, and scalability through prototyping. Collaborating alongside leaders in Implantable Device Technologies and...

Biogen Head of Medical Omnichannel, Digital, & Innovative Engagement North America Medical Job Description The Head of Medical Omnichannel, Digital, & Innovation Engagement will be part of the North America Medical Leadership Team and will develop and lead the Scientific & Value Communication function within North America Medical, serving as a strategic partner within Biogen to inform medical practice across our therapeutic areas and pipeline. Reporting to the Head of North America Medical, this high-impact position will implement cutting-edge strategies that integrate traditional scientific communications with innovative digital tools, artificial intelligence, and multichannel platforms. The successful candidate will shape our scientific narrative across Biogen's therapeutic portfolio while building next-generation capabilities that amplify our scientific impact and enable measurable patient outcomes. Through a cross-functionally accepted Scientific...

Biogen About This Role As the Head of Translational Immunology, you will play a critical leadership role in driving innovation and advancing the organization's research and development initiatives. You will join a dynamic team dedicated to the discovery, development, implementation, and interpretation of translational and clinical biomarker strategies to support the Immunology portfolio. Key responsibilities include leading the design, execution, and integration of biomarker strategies from early Research through early clinical development. A central focus of this role is advancing innovative translational approaches that integrate diverse human datasets-including genomics, transcriptomics, proteomics, cellular models, and clinical data-to inform novel therapeutic targets, generate actionable hypotheses, and provide supporting evidence for programs across the Immunology pipeline. What You'll Do Strategic Leadership and Team Building Lead and mentor a...

Biogen About This Role The Biomarkers and Systems Biology group is seeking a highly motivated Senior Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development, optimization, and validation of bioanalytical assays supporting early and latestage clinical studies. The Senior Scientist will lead immunogenicity strategy, provide scientific oversight of CROexecuted assays, and contribute to global regulatory submissions. The ideal candidate has deep expertise in pharmacokinetic and immunogenicity bioanalysis, with additional experience in biomarker methods. Handson assay development experience across multiple platforms and a strong understanding of regulatory expectations are essential. The role requires scientific rigor, sound judgment, and the ability to operate effectively in a fastpaced biotech environment. What You'll Do Lead development,...

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...

Biogen This is a remote position that requires the candidate to be located in the United States. 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 senior management....

Biogen About This Role: As the Associate Director, Integrated Insights & Analytics, you will be a pivotal member of the US Decision Sciences team, working closely with the US Brand team to uncover actionable customer and market insights for a single inline or pipeline asset across indications. You will lead the charge in crafting the integrated insights narrative for this asset, integrating both primary research and secondary data to create executive-ready storytelling that informs brand and launch decisions. Your role will significantly influence the strategic direction by synthesizing complex data into clear insights that shape brand priorities and align with decision points. This is an individual contributor role, yet integral to the success of the brand, providing crucial insights that drive business decisions. What You'll Do: Serve as the go-to insights partner for the asset, aligning work to brand priorities and decision points Own the integrated insights...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen About This Role As a Sr. Engineer III in Manufacturing Sciences, you will be an integral member of the global Manufacturing Sciences team. Your primary focus will be on leading, facilitating, and coordinating biologic molecule technology (tech) transfer activities at our Bio Site in RTP. You will create, drive, and communicate technology transfer deliverables while managing the overall tech transfer schedule and metrics. By utilizing technical rigor, analyzing complex issues and identifying business process optimization opportunities, you will provide technical leadership, strategic insights and direction. Your role also involves communicating transfer plans and risk mitigations to senior leadership, ensuring alignment with departmental priorities. This position is pivotal for driving successful tech transfers, supporting both internal programs and those of our strategic partners, and enhancing the value to our business What You'll Do: Coordinate and lead tech...

Biogen About This Role This enterprise-level role sets the strategic direction for global scientific communications and ensures Biogen delivers consistent, credible, and innovative scientific exchange across all channels. The Senior Director, Head of Scientific Communications Excellence & Innovation is a strategic partner within Global Medical Affairs, responsible for building and leading Biogen's worldwide scientific communications capability. This role ensures consistent, compliant, and impactful scientific communications across publications, congresses, and emerging digital/omnichannel platforms to support high-quality scientific exchange across the Medical organization. Through the strategic development and implementation of cross-functionally accepted global frameworks, governance, and ways of working, this role enables Medical teams to shape and deliver a coherent scientific narrative across geographies and the asset lifecycle. As the enterprise owner for...

Biogen As the Pharmacovigilance Agreement (PVA) Senior Manager, you collaborate with varied levels of cross-functional internal and external global stakeholders in all aspects of timely execution and maintenance of safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) with Corporate Partners. The PVA Senior Manager is integral to the planning, visualization, and archival systems required for on-time development and marketed product SDEAs, PV transfer agreements, and for inspection readiness. This individual contributor role reports to the Head of PV Alliance Management (PVAM) and contributes directly to Biogen's product pipeline and portfolio. What You'll Do Conduct timely outreach for SDEA planning, authoring and stakeholder and corporate partner transparency Manage the SDEA tracker and produce accurate SDEA planning reports and other required status reports Act as an SDEA subject matter expert for audit and inspections and SDEA inbox...

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 AboutThis Role The Director, Integrated Insights and Analytics Lead - Rare Disease,is a Therapeutic area facing role, enabling data-driven decisions, and proactively delivering actionable insights. This position will allow you to shape the Rare Disease cross-functional team, a top priority for Biogen North America, laying the groundwork for processes that can be scaled across other brand teams. This position offers an extraordinary opportunity to innovate and evolve Biogen's industry-leading portfolio, improving patient outcomes for millions. Responsibilities include insights and analytics, including primary marketing research, secondary analytics, forecasting guidance, and competitive intelligence.The role reports intoSenior Directorof Decision Sciences andis a core member of thefranchise leadership team As the key partner to commercial and marketing leadershipand a member of the Decision Sciences, you will help identify& addressthe most important...

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...

Biogen About This Role As a Principal Application Specialist, you will play a critical role in designing, building, implementing, and maintaining Veeva Vault Document Management System. Biogen is undergoing a business transformation with technology as a core enabler. Veeva Vault QualityDocs is a critical component of this transformation, and you will be the ultimate driver, leveraging your expertise to ensure high-quality service delivery, optimal system performance, and seamless user experiences. Acting as the IT System Owner for Veeva Vault QualityDocs, you will collaborate closely with cross-functional teams, including business analysts, technical architects, system configurators and project managers, to deliver upgrades, enhancements, new modules, and other initiatives aligned with strategic business roadmaps. Your work will directly support Biogen's Employee Experience and GxP compliance, ensuring that our document management system meets regulatory requirements and user...

Biogen Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. About This Role: As Associate Director, Biostatistics, you will be at the forefront of leading study design and data analysis, providing statistical expertise for our products across various therapeutic areas. Your role is crucial in clinical development, biomarker development, research, and beyond. Acting independently, you will provide statistical input in scientific discussions, participate in protocol development, and oversee analysis plans and report specifications. You'll play a key role in reviewing study setup activities, ensuring the integrity of randomization and CRFs, and leading biostatistical efforts for assigned projects. Your work involves performing...

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 Develop process of overseeing the full lifecycle of PLAI data across research, development, and quality functions 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...