Senior Biostatistician - Clinical Development & Regulatory
Precigen, Inc
Precigen, Inc. is seeking a Senior Biostatistician to lead sponsor-driven statistics across Clinical Development and Medical Affairs, partnering with Clinical Development, Medical Affairs and Regulatory to ensure robust study design and analysis. The role requires directing CRO biostatistics, overseeing SDTM/ADaM workflows, and guiding endpoint selection, adaptive designs, and regulatory reporting with strong communication to stakeholders. #J-18808-Ljbffr Precigen, Inc
- ...Nasdaq-listed biopharmaceutical company, seeks a Senior Biostatistician in Germantown, MD to lead statistics for sponsor... ...with sponsor standards, partnering with Clinical Development, Medical Affairs and Regulatory. You will design analyses for Phase 3b/4 and real...SeniorRegulatory
- ...Senior Biostatistician Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company... ...-generation activities across Clinical Development and Medical Affairs. Statistical programming... ...Development, Medical Affairs and Regulatory. Duties and Responsibilities:...SeniorRegulatoryInterim role
- ...Job Description Job Description Senior Clinical Scientist, Clinical Development Our Client: Our client is developing a novel bispecific agonist... ...informed consent forms (ICFs), protocol amendments, regulatory briefing documents, and Clinical Study Reports (CSRs...SeniorRegulatoryInterim role
- Overview Sr. Biostatistician Manager Be Part of One Team,... ...shaping the future of clinical research- where human... ...and accelerating the development of life-changing... ...and oversight to other senior statistical staff and... ...Represents Emmes at Sponsor, Regulatory, Investigator or...SeniorRegulatoryContract workCasual workLocal areaRemote workWork from homeFlexible hours
- ...neuroscience. Overview Associate Biostatistician Be Part of One Team, One... ...’re shaping the future of clinical research— where human... ...trials and accelerating the development of life-changing therapies.... ...monitoring committees and regulatory bodies. Contributes to manuscripts...RegulatoryCasual workLocal areaWork from homeFlexible hours
- Clinical Dynamix, Inc. is seeking an experienced Senior Scientist/Manager to lead Process Development and MSAT for our cell therapy pipeline. You will design, optimize, and scale manufacturing... ...across R&D, Manufacturing, Quality, Regulatory, and Clinical teams. The role requires...SeniorRegulatory
- ...(with proximity to Radnor, PA) seeks an Associate Director of Clinical Operations to lead the operational delivery of complex programs... ...successful candidate will guide study strategy, contribute to regulatory documentation, and ensure program-wide coordination from...SeniorRegulatory
- A clinical research organization is seeking a Biostatistician to collaborate with clinical investigators and contribute to protocol development. The role includes statistical analyses and the generation of clinical study reports. Candidates should have a PhD in biostatistics...Remote jobWork from home
- Emmes Group is a leading clinical research organization seeking an Associate Biostatistician to support biostatistics activities on one or more studies. You will... ...support analyses, and generate reports for DSMBs and regulatory bodies. The role emphasizes independence,...Regulatory
$233.59k - $350.38k
...Job Title: Senior Global Clinical Development Scientist Director Flexible to be based in Gaithersburg, MD or Barcelona Missisauga Introduction... ...with clinical practice, the evolving scientific and regulatory landscape, and program objectives.- Protocol Ownership...SeniorRegulatoryHourly payTemporary workWork at officeWorldwideFlexible hours3 days per week$140k - $155k
...Regulatory and Clinical Full-time Regular Professional - STAFF Germantown, MD, US Salary Range... ...diseases. POSITION SUMMARY: The Senior Clinical Trial Manager (SCTM) is responsible... ...-ready. Studies may sit in Clinical Development or Medical Affairs. DUTIES AND...SeniorRegulatoryFull timeContract work$150k - $165k
...alternative application process. Senior Manager, Clinical Data Regulatory and Clinical Full-time Regular Germantown... ...sponsored study, across Clinical Development and Medical Affairs. Data... ...in hand with study leads and the Biostatistician so data are fit for analysis, submission...SeniorRegulatoryFull time- Emmes is seeking a Manager, Regulatory Affairs to lead regulatory strategy for multiple clinical development programs. The role combines advisory leadership with hands-on regulatory submissions and a focus on US FDA interactions, INDs, and approval pathways. Based in the...SeniorRegulatoryRemote job
$203.21k - $304.82k
...sponsorship) to make it real. As Senior Director, AI for Clinical Intelligence & Evidence, Breast &... ...You will work closely with drug development teams to translate complex clinical... ...trial and real-world data to support regulatory, HTA and payer-grade evidence, establish...SeniorRegulatoryTemporary workWork at officeImmediate startFlexible hours3 days per week- ...Process Development & MSAT Sr Scientist / Manager - Cell Therapy... ...seeking a hands-on, experienced Senior Scientist or Manager to drive... ...development into internal clinical manufacturing or external CDMO... .... Documentation & Regulatory Enablement: Author and review...SeniorRegulatoryPermanent employmentImmediate start
$96k - $144k
...seeking a highly motivated Senior Process Engineer to support... ...-stage cell therapy process development, process characterization, PPQ... ...demonstrates success in supporting clinical and commercial readiness.... ...and platforms. Regulatory Support Contribute to authoring...SeniorRegulatoryTemporary workShift work- OpenText, a global leader in information management, is seeking a Senior Product Marketing Manager to own messaging and positioning for... ...engineering and QA leaders, and compliance owners, weaving in regulatory proof points across the messaging. You will track competitors...SeniorRegulatory
- ...Description AbelZeta is a clinical stage biopharmaceutical company... ...on the discovery and development of innovative and proprietary... ...Operations, the Clinical Trial Senior Manager will be a key member... ...translational research, and regulatory teams. CRO and vendor management...SeniorRegulatoryContract workTemporary work
$288.06k
Senior Global Development Medical DirectorAstraZeneca is seeking a Senior Global Development Medical Director to provide clinical and scientific leadership across global development programs in... ...with the Global Clinical Head, regulatory agencies, external medical experts...SeniorRegulatoryFull timeTemporary workWork at officeWorldwide3 days per week$120k - $140k
...$140,000.00/yr Job Details Remote Senior CRA position in the oncology space. Jobot... ..., reviews, and monitors required regulatory documents for study start‑up, study maintenance... ...management. Works with in‑house Clinical Trial Assistant to collect, review, and...SeniorRegulatoryInterim roleLocal areaRemote workFlexible hours- ...AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful regulatory projects at a dynamic organization with global reach.... ...CMC compliance.Job DescriptionOverviewLead regulatory strategy development and implementation for pharmaceutical products in development...SeniorRegulatory
- CenExel Clinical Research in Gaithersburg, MD seeks an Assistant Nurse Manager to support the delivery of high-quality clinical... ...Nurses and Psychiatric Technicians and collaborate with senior leaders to ensure regulatory compliance and optimal patient care. This role partners...RegulatoryWork at office
$95k - $115k
...Description Job Description Job Title: Senior Manager, Clinical Operations Location: Derwood, MD... ...sites, and compliance with all regulatory standards. The Senior Manager... ...affecting clinical operations. Training & Development · Lead development and delivery of...SeniorRegulatoryWork at office$107.9k - $195.05k
...Senior Systems Engineer – Agile Team Systems EngineeringLeidos is seeking Senior Systems... ...the Homeland Sector, supporting the development of next-generation flight service and air... ...You will ensure that operational needs, regulatory requirements, and system-level behaviors...SeniorRegulatoryFull timeRemote work- ...PharmaceuticalsSelling Points Lead impactful regulatory strategies in a dynamic pharmaceutical... ...Manager Regulatory Affairs OverviewThe Senior Manager Regulatory Affairs will lead... ...strategies for pharmaceutical products in development and post-approval stages.This hybrid role...SeniorRegulatory
$101.64k - $152.46k
...analysis and decision support - scaling from early process development through late-stage clinical development and commercial and post-commercial... ...priorities, and deliver under time-sensitive program and regulatory timelines • Practical problem-solving with ability to...SeniorRegulatoryHourly payTemporary work$15 - $18 per hour
FSP Senior Clinical Development Program Coordinator FSP Senior Clinical Development Program Coordinator 3 weeks ago Be among the first 25 applicants Direct message the job poster from ProPharma The Clinical Development Program Coordinator will provide support to the Clinical...SeniorFull timeFor contractorsWork at office- The OpportunityWe are seeking a visionary Senior CRM Product Owner to spearhead the... ...Global Core" baseline to meet unique U.S. regulatory and market demands.Establish feedback loops... ...data integrity across disparate clinical and commercial sources.Agile LeadershipProven...SeniorRegulatoryHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week
$218.06k - $327.09k
...our science reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy... ...leadership and has expertise in global regulatory science, drug development processes, and strategies for high-profile programs....SeniorRegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$119.85k - $179.77k
...Senior StatisticianThe Senior Statistician has sufficient experience... ..., preclinical studies, regulatory submissions and/or commercialization... ...for preclinical or clinical programs, high level internal... ...inform design decisions and the development of decision criteriaDevelop...SeniorRegulatoryTemporary work
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