Senior Biostatistics Lead - Strategy & Regulatory Submissions
System One Clinical & Science
System One Clinical & Science in Wayne, PA seeks a Sr. Manager/Associate Director of Biostatistics to lead statistical strategies for late-stage programs. The role partners with Clinical Development, Medical and regulatory teams to shape study design, analyses, and regulatory submissions. The ideal candidate holds a Ph.D. in Biostatistics or related field with extensive pharma experience, demonstrates leadership across cross-functional teams, and guides external CROs and statisticians to deliver #J-18808-Ljbffr System One Clinical & Science
- ...seeking a Biostatistician who will provide biostatistics consulting throughout all phases of... ...development, ensuring compliance with regulatory requirements. The ideal candidate will... ...role involves close collaboration with senior management, mentoring junior staff, and...SeniorRegulatory
- CSL Behring seeks a Senior Manager, Regional Regulatory Lead - US Hematology to guide US regulatory strategy within Global Regulatory Affairs. You will interact with FDA, shape regional submissions, and collaborate across cross-functional teams to align on global regulatory...SeniorRegulatory
- CSL Behring seeks a Senior Manager, Regional Regulatory Lead - US Hematology to drive US regulatory strategy within a global framework. The role focuses on FDA interactions, submissions, and regulatory planning for hematology products. Location options include King of Prussia...SeniorRegulatory
- CSL Behring seeks a Senior Manager, Regional Regulatory Lead - US Hematology to join Global Regulatory Strategy. You will guide US regulatory strategies, oversee submissions, and partner with regulatory and cross-functional teams to navigate FDA requirements for developmental...SeniorRegulatory
$150k - $180k
Senior Manager, Regional Regulatory Lead - US Hematology CSL Research & Development Location: King of Prussia... ...to join Global Regulatory Strategy (GRS) within Global Regulatory Affairs... ...regulatory strategy, product development, submissions, and health authority interactions...SeniorRegulatoryWorldwide3 days per week$137k - $235.75k
...best talent for a Senior Manager, Global Diagnostic Lead, Oncology Precision... ...Diagnostic Strategy and Program Leadership... ...development plan, regulatory strategy, and anticipated... ...Affairs, Biostatistics, Clinical Operations... ..., investigational submissions, responses to health...SeniorRegulatoryContract workLocal area- ...capability, and we're looking for a Senior Director of Search &... ...Director of Search & Evaluation to lead strategic sourcing and... ...Team, influencing therapeutic strategy and integrating late-stage external... ..., coordinating clinical, regulatory, commercial, and market access...SeniorRegulatoryFull time3 days per week
$264k - $322k
...our shared purpose: leading the fight against... ...strengthening our workforce strategy to ensure we have... ...the right way.The Senior Director of Biostatistics is an individual... ...contributing to regulatory documents. In addition... ...strategies, submission documents and lifecycle...SeniorRegulatoryMinimum wageFull timeLocal areaFlexible hours$96.68k - $120.85k
...selected candidate will lead and support... ...technical specialists.As a senior member of the team, you... ...investigation and remediation strategies, oversee field... ...deliverables, and support regulatory and client... ...finalization through final submission of technical documents...SeniorRegulatoryFull timeWork at office$175k - $200k
...Title: Sr. Manager/ Associate Director, Biostatistics Location: Wayne, Pennsylvania Type:... ...to directly influence study strategy, regulatory submissions, and the path to potential commercialization. Responsibilities Lead the biostatistics strategy for one or...SeniorRegulatoryPermanent employmentFull timeInterim roleLocal area- CSL Behring is seeking a Senior Manager, Regulatory Submission to lead global submission management activities and coordinate with Regulatory, Publishing, and cross-functional teams. You will oversee vendor relationships and ensure timely, compliant submissions across markets...Regulatory
- CSL Behring is seeking a Director, Media Strategy & Performance to lead U.S. portfolio media strategy across consumer and healthcare professional... ...build repeatable planning playbooks while aligning with regulatory requirements in a complex, regulated environment. #J-188...Regulatory
- GlaxoSmithKline is seeking a CMC Regulatory Affairs professional to lead global regulatory activities from early... ...management. You will shape strategy, ensure compliance, and collaborate... ...manufacturing teams to facilitate timely submissions. You will influence cross-...Regulatory
- CSL Plasma in King of Prussia, PA is seeking a Senior Manager, Regulatory Submission. This hybrid role teams with Global Regulatory Submission Management to ensure timely, high-quality regulatory submissions across markets. You will coordinate with Regulatory, Project Management...Regulatory
- CSL Plasma Inc. invites applications for a Senior Manager, Regulatory Submission. This hybrid role requires coordinating global regulatory submissions... ...submissions across markets. The successful candidate will lead publication activities, assess risks to timelines, and...Regulatory
- Scorpion Therapeutics is seeking a Senior Scientist, Global Labeling Lead to develop and maintain compliant labeling... ...labeling guidance, and act as the regulatory labeling contact for global submissions, shaping labeling strategies for regulatory authorities. #J-18808...Regulatory
$264k - $322k
...Madrigal Pharmaceuticals seeks a Senior Director of Biostatistics to lead statistical activities across... ...drive clinical development strategy Oversee biostatisticians and... ...Plans Contribute to clinical/regulatory strategies and submission documents for program...SeniorRegulatory- ...Johnson & Johnson seeks a Senior Manager to lead global diagnostic strategies supporting oncology precision medicine drug development. This developmental... ...diagnostic strategies aligned with clinical development and regulatory plans Independently lead defined diagnostic...SeniorRegulatory
- Kaztronix LLC seeks a strategic Director, Regulatory Affairs to guide global regulatory... ...through potential registration. You will lead submissions, health authority interactions, and lifecycle... ...with cross-functional teams and senior leadership to drive milestones and ensure...Regulatory
- ...LeadershipServe as technical lead for workforce identity platforms... ...and supplier‑risk mitigation strategies.Document existing and new... ...validation Incident response Regulatory and audit requirements (SOX,... ...executive‑ready communication.Mentor senior and mid‑level engineers and...SeniorRegulatoryFull timeVisa sponsorship
- ...headquarters. You will partner with benefits, HR operations, and compliance to ensure accurate enrollment, timely communications, and regulatory compliance across the U.S. and Canada. Responsibilities include open enrollment, 401(k) audits, and annual renewals, plus vendor...SeniorRegulatory
- Merck is seeking an experienced statistical programmer lead within BARDS to drive analysis and reporting across late-stage drug... ...complex datasets, tables, listings, and figures for regulatory submissions and post-marketing support. The role requires strong SAS expertise...SeniorRegulatory
- ...programs and workstreams.Money Movement Strategy & Client ExperienceIdentify opportunities... ...management, and operational efficiency.Lead modernization of money movement policies... ...payments, or wealth management.Knowledge of regulatory and compliance considerations related to...SeniorRegulatoryFull time
- ...Director, Real World Data Strategy and External Partnerships Lead will be accountable for... ...jointly with relevant senior leaders. Develop deep relationships... ..., reliable data with regulatory and external stakeholder... ...field (Epidemiology, Biostatistics, HEOR, data science)...RegulatoryLocal areaRelocation
- Role: Senior Scientist, Global Labeling Lead, responsible for developing and maintaining compliant... ...: ensure high-quality, regulatory-compliant labeling documents... ...labeling contact for global submissions; develop labeling strategies and language for regulatory authorities...SeniorRegulatory
$150k - $220k
Job Summary The Senior Manager, Enterprise Delivery Strategy is responsible for defining and leading the strategic software delivery capability across the Enterprise Technology... ...accelerate innovation while supporting regulatory and compliance requirements. Leadership &...SeniorRegulatoryFull timeWork at officeLocal areaFlexible hours3 days per week1 day per week- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products.... ...approvals. Your leadership will guide global submissions, change controls, and regulator interactions,...Regulatory
- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...Regulatory
- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is... ...stakeholders to address regulatory strategy challenges and deliver... ...the development and submission of high-quality, compliant... ...delivery.Demonstrated ability to lead cross-functional teams and...SeniorRegulatoryFull timeLocal areaFlexible hours
$109k - $174.8k
...Johnson & Johnson seeks a Senior Programming Lead to oversee oncology clinical trial programming... ..., and oversee programming strategy and execution for one or more clinical... ...oversight to achieve project goals and regulatory submissions Contribute to departmental innovation...SeniorRegulatory
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