Senior Biostatistician — Regulatory & Clinical Data Expert
$100.27k - $162.29kColoplast
Coloplast in Minneapolis, MN is seeking a Senior Biostatistician to provide statistical expertise in clinical research and regulatory submissions. This highly collaborative role involves working with cross-functional teams and ensuring sound statistical methodology in product development. The ideal candidate will hold an MS in Statistics and have 3–7 years of experience in the medical device or pharmaceutical industry. The position offers comprehensive benefits including a competitive salary range of $100,274 to $162,287 annually. #J-18808-Ljbffr Coloplast
$84.9k - $106.1k
...position reports to the Associate Director, Clinical Data Management, Oncology and is part of the... ...and compliant clinical trial data. The Senior Clinical Data Associate (Sr. CDA) works... ...standards, SOPs, and applicable regulatory requirements. Perform other assigned...SeniorRegulatoryInterim roleWork at officeLocal areaRemote workWorldwideFlexible hours$100.27k - $162.29k
Senior Biostatistician Provides statistical expertise to support clinical research, regulatory submissions, and product development activities. This role is responsible for the design... ...(DOE), test method validation, and data analysis to support product and process development...SeniorRegulatoryContract workImmediate startFlexible hours- ...Are you an experienced Senior Manager, Clinical Trials with a desire to excel? If so, then Talent Software... ..., budgets, quality standards, and regulatory requirements. The Senior Manager... ...across assigned studies. Provide clear, data driven study updates, risk assessments...SeniorRegulatoryContract work
$112.7k - $193.2k
...Minnesota School of Nursing is looking for a Senior Clinical Program Manager to enhance the use of... ...collaborate with teams, and ensure compliance with regulatory standards. Candidates should have a Master's degree and experience in data analysis and durable medical equipment...SeniorRegulatoryRemote job$222.4k - $278k
...the Role Reporting to the Head of Clinical Development, the individual in this role... ...development, including multiple anticipated regulatory interactions. In addition, this... ...analysis and interpretation of clinical data (safety and efficacy) and a working knowledge...SeniorRegulatory- ...strongly preferred. Job Purpose: The Clinical Research Associate (CRA) has local... ...are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification... ...Updates CTMS and other systems with data from study sites as per required timelines...SeniorRegulatoryLocal areaRemote workFlexible hoursShift work
- ...aspects for implementation of one or more clinical trials and all activities from study... ...Interactive Response Technology (IRT), Electronic Data Capture (EDC), eDiary and other systems... ...ensure their compliance with required regulatory and GCP quality standards and...SeniorRegulatoryContract workRemote work
$260k - $350k
...Title: Senior Medical Director Location: Remote Position Summary... ...into the Vice President, Clinical Development. You will be... ...department and the company to regulatory standards and procedures.... ...Drive clinical database design, data collection and cleaning and oversees...SeniorRegulatoryContract workRemote work$284.32k - $355.4k
...individual for the position of Senior Medical Director, Clinical Research (Ophthalmology)... ...up and design including data collection tools, data... ...with appropriate scientific/regulatory/medical standards ~ Contributes... ...as the subject matter expert for ophthalmology,...SeniorRegulatoryWorldwideFlexible hours$102k - $162k
Senior Clinical Research Associate The Senior Clinical Research Associate is responsible for developing... ..., ensuring adherence to ISO/FDA regulatory requirements, Good Clinical Practice (... ...and study objectives to ensure robust data integrity and study execution. Your role...SeniorRegulatoryFull timeWork at officeRemote workWork visa3 days per week$112.7k - $193.2k
...Connecting. Growing together. As a Senior Clinical Program Manager - Devices... ..., internal policies, and regulatory requirements Support program... ...Serve as a subject matter expert and liaison to address cross... ...field Solid experience with data analysis and interpretation,...SeniorRegulatoryMinimum wageFull timeWork experience placementLocal areaRemote work$186.4k - $279.6k
...clinicians with education and clinical guidance to improve patient... ...scientifically valid, meeting regulatory requirements, and are conducted... ...serving as a subject‑matter expert Setting and communicating... ...selection and management, Electronic Data Capture systems management,...SeniorRegulatoryTemporary workH1bWork at officeLocal areaFlexible hours- ...availability. Our consultants step into communities that truly need their expertise, providing stability and guidance in areas like regulatory compliance, staffing challenges, turnover, and risk mitigation. Key Responsibilities: Serve as interim leadership (e.g.,...SeniorRegulatoryInterim roleMonday to FridayWeekend work
- ...The Senior Clinical Quality Program Manager leads the coordination and execution of complex, enterprise-wide clinical quality programs... ...multiple interconnected workstreams. This role ensures alignment, regulatory compliance, and effective management of project...SeniorRegulatoryFull timeWork experience placement
$70 - $90 per hour
...Description Insight Global is looking for a Senior Clinical Trial Manager to provide strategic and... ..., budgets, quality standards, and regulatory requirements. The Senior Manager drives... ...mitigation. The role provides clear, data‑driven updates and recommendations to clinical...SeniorRegulatory- ...Description Position Description: The Sr. Clinical Research Specialist (Sr. CRS) will... ...deliverables consistent with applicable regulatory standards and internal Medtronic requirements... ...Assist in the preparation and review of data Oversee follow-up and resolution of...SeniorRegulatoryFor contractors
- ...Sr. Clinical Trial Manager - Hybrid Primary Location: Maple Grove, Minnesota V-Soft Consulting... ...of GCP, ICH guidelines, and global regulatory requirements. Proven ability to manage complex... ...regulatory submissions. Provide clear, data driven study updates, risk assessments,...SeniorRegulatoryCurrently hiringLocal areaRemote work
- ...specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and... ...deliverables consistent with applicable regulatory standards and internal Healthcare... ...Assist in the preparation and review of data · Oversee follow-up and resolution of sites...SeniorRegulatoryLocal area
$60.7k - $106k
...Technology Solutions team, the Senior Technical Writer role for... ...for a range of embedded drug data and Clinical Decision Support solutions.... ...Support relevant healthcare regulatory requirements (e.g., HIPAA, FDA... ...with impact. We provide expert software and information solutions...SeniorRegulatoryFull timeWork at officeRemote workWorldwide- ...Senior Data Scientist We are seeking a Senior Data Scientist with... ...impact business performance, clinical workflows, and decision-making... ...Acts as a subject matter expert Problem Solving Solves... ...to all quality systems and regulatory requirements Integrates quality...SeniorRegulatory
$310k - $375k
...Senior Medical Director - Clinical Research About Pharming Pharming Healthcare Inc. is a global biopharmaceutical... ...start-up, close-out, oversight, and regulatory support) for napazimone studies... ...programs Analyze and oversee data from clinical trials and produce...SeniorRegulatoryTemporary workWork experience placementRemote workFlexible hours- ...Clinical Informaticist The Clinical Informaticist will bridge the... ...Analyze clinical data and develop data mapping and... ...them innovative solutions and expert guidance. Our suite of services... ...optimizations, data conversion, regulatory and quality reporting, enterprise...RegulatoryShift work
$145k - $180k
...Senior Clinical Project Manager About Pharming Pharming Healthcare Inc. is a global... ...team, Pharmacovigilance, Supply Chain, Regulatory Affairs, Quality Assurance - requiring... ...Oversee process and aspects of timely data cleaning, data analysis and the reporting...SeniorRegulatoryTemporary workWork experience placementLocal areaRemote workFlexible hours- ValueBase Consulting is looking for a CMC Regulatory Affairs Consultant to manage CMC submissions for clinical trials remotely. Candidates should have a Bachelor’s Degree or higher, with 10+ years in life sciences and 5+ years in regulatory affairs. The role involves developing...SeniorRegulatoryRemote job
- ...work schedule Position Summary: The Data Specialist assists in the review of... ...record documentation, abstract, and enter clinical data into registry software Ensure timeliness... ...abstraction deadlines to comply with regulatory / stakeholder requirements Maintain...RegulatoryFull timeWork experience placementWork at officeRemote work
- ...of Minnesota is hiring a Senior Submissions/Encounter Healthcare Data Analyst in Eagan, MN. In... ...quality assurance, and regulatory submissions with a focus... ...dashboards and leverage expert-level SQL skills to ensure... ..., technical, and/or clinical. ~ High school diploma...SeniorRegulatoryFor contractorsWork at officeRemote work2 days per week
$102.1k - $194k
...Senior Product Manager, EP Competitive Strategy Work mode: Hybrid... ...PFA market Analyze market data and present data trends to... ...abreast of industry trends, regulatory changes, and technological advancements... ...and competitive product clinical data Collaborate with...SeniorRegulatoryWork at officeLocal areaFlexible hours3 days per week- Senior Manager Regulatory Ad/Promo (PR/592530) Minneapolis, Minnesota A leading global medical device company is seeking a Regulatory Affairs... ...promotional review documentation Collaborating with Medical, Clinical, Legal, Quality, and Product teams Participating in...SeniorRegulatory
- ...Senior Medical Director, Watchman Boston Scientific is hiring... ...Your expertise will guide our clinical strategy, working closely with... ..., study investigators, and regulatory agencies. Collaborate with... ...presenting and discussing clinical data with peers/clinical community...SeniorRegulatoryLocal area
- ...manufacturing readiness, audits, and clinical builds to ensure a smooth... ...the quality system. • Data & Continuous Improvement: Compile... ...and change orders. Evaluate regulatory impact of equipment changes... ...Support audits as Subject Matter Expert (SME) for QMS processes and...SeniorRegulatory
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