Regulatory Biostatistician for FDA Submissions
Tunnell Government Services
Tunnell Government Services, Inc. is seeking a full-time Biostatistics Consultant to support FDA regulatory programs, applying statistics to regulatory submittals and clinical data assessments. The role emphasizes collaboration with federal personnel, adherence to 21 CFR guidelines, and rigorous data analysis in support of device safety and effectiveness. On-site work in the Bethesda area is anticipated, with potential remote meetings as needed. #J-18808-Ljbffr Tunnell Government Services
- ...Health (CDRH), Food and Drug Administration (FDA) Duty Description: The contractor... ...Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices LINK... ...assessment of statistical aspects of regulatory submissions. These analyses should align with...RegulatoryFull timeFor contractorsWork at officeRemote work
- ...Biostatistician The Biostatistician will provide statistical and statistical-programming... ...25). The Biostatistician will develop FDA-ready, CDISC-compliant deliverables, execute... ...Plan (SAP), and support generation of regulatory-submission outputs required for FDA filing and...RegulatoryFull timeContract workTemporary workPart timeFor contractorsWork at officeShift work
- Cherokee Federal is seeking a Clinical Biostatistician to support a Phase 2a clinical trial evaluating a hantavirus... .... This role involves statistical programming, FDA-compliant dataset development, and regulatory submission outputs. The ideal candidate will hold a master'...Regulatory
- Venesco, LLC is seeking a Senior Regulatory Affairs Scientist to lead submission strategies and regulatory interactions for innovative medical products. This... ...regulatory affairs experience and a strong grasp of FDA regulations and ICH guidelines. Responsibilities include...RegulatoryFull time
$75k - $85k
A regulatory affairs organization in Bethesda is seeking a Regulatory Specialist to manage regulatory submissions and scientific document preparations. The role requires a Bachelor's Degree and strong communication skills. Candidates should have knowledge of Microsoft Office...RegulatoryWork at officeRemote work- Overview Biostatistician US Remote Emmes Group: Building a better future for us all. Emmes Group is transforming the... ...distributed to internal and external monitoring committees and regulatory bodies; Participating in professional development...RegulatoryCasual workLocal areaRemote workWork from homeFlexible hours
- Overview Senior Biostatistician US Remote Emmes Group: Building a better future for us all. Emmes Group is transforming... ...publications. Represents EMMES on behalf of clients at regulatory meetings. Participate in the development and updating of...RegulatoryCasual workLocal areaRemote workWork from homeFlexible hours
- CHEManager International seeks a Senior Regulatory Affairs Scientist to lead submission strategies and regulatory interactions for innovative medical products... ...submissions, and serve as the primary liaison with FDA and other agencies, guiding cross-functional teams to...Regulatory
- Frederick National Laboratory for Cancer Research seeks a Regulatory Affairs Associate to support IND readiness and regulatory submissions. You will coordinate documentation, liaise with NIH teams, CROs, and vendors, and ensure compliant, submission-ready files. The role...Regulatory
- AstraZeneca is seeking a Regulatory Affairs Manager to lead end-to-end regulatory deliverables across global markets. You will coordinate submission strategies, assess risks, and guide cross-functional teams on regulatory requirements throughout the product lifecycle. The...Regulatory
- AstraZeneca in Gaithersburg, MD is seeking an energetic Regulatory Affairs Associate to support licenses and applications aligned with... .... You will manage document control, assist with simple submissions, and act as an interface with Health Authorities while mentoring...Regulatory
$95k - $125k
...support risk determinations in the context of regulatory review. Note: This is a support role.... ...exclusive responsibility of qualified FDA federal employees. The contractor's... ...inadequately presented in sponsor submissions, for FDA reviewer finalization and issuance...RegulatoryPermanent employmentContract workFor contractorsWork experience placementLocal areaShift work- Overview Senior Biostatistician Manager - US Remote Emmes Group: Building a better future for us all. Emmes Group is transforming the... ...and growth for senior staff. Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety...RegulatoryContract workCasual workLocal areaRemote workWork from homeFlexible hours
$60 - $65 per hour
...Description Job Description Job Title: Biostatistician Location: Remote Job Type:... ...outputs, and ensuring compliance with regulatory standards. Key Responsibilities... ...Clinical Study Reports (CSRs) and regulatory submission data. Perform statistical analyses...RegulatoryRemote jobFor contractors- AstraZeneca is seeking a Regulatory Affairs Associate to support regulatory management and license applications in line with AZ standards. You will manage regulatory files, assist with submissions, and serve as an interface with Health Authorities for task execution. The...Regulatory
- ...Senior Biostatistician Location: Silver Spring, MD; Hybrid remote/on-site EMKS is seeking a Senior Biostatistician in support of the Defense Health Administration Traumatic Brain Injury Center of Excellence. Duties/Responsibilities: The Senior Biostatistician...For contractorsWork at officeRemote work
- ...Biostatistician II Location MD - Silver Spring Job Code 14153 Salary Range of openings 12 Apply Now ( Bering-Alaka`ina Holdings, LLC has a potential need for a Biostatistician II to provide support for our government customer in Silver Spring, MD. DESCRIPTION...Work at office
$90k - $120k
Do you enjoy working directly with researchers to solve genome-submission problems and prepare high-quality genomic data for public release? Computercraft is seeking a Genome Data Curator/Molecular Biologist to support the National Center for Biotechnology Information...3 days per week- ...care and enrichment activities to maintain a clean, safe and regulatory compliant animal research program. Work with staff to manage... ...at the time required. Update animal protocol through the submission of amendments and submission of new animal protocols to ensure...RegulatoryContract workWork at office
- ...global regulations for the reporting of adverse events to regulatory agencies Develops and ensures the uniform and timely processing... ...event reconciliation Preparation of IND safety reports for submission to the FDA; safety document or data analysis Clinical trial site...RegulatoryFull timeWork at officeLocal areaRemote work
- Regulatory Specialist - (RS001_COMPANY_1.5) Share this job as a link in your status update... ...Prepare, distribute, and track regulatory submissions including, drug and biologic... ...accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations...RegulatoryFull timeWork at officeLocal areaRemote work
- Join the HJF Team! HJF is seeking a Biostatistician I to provide biostatistical support for clinical and/or laboratory research. This involves performing statistical analysis on data collected from clinical trials and/or research studies. The Biostatistician I participates...
- Federallabs is seeking a Biostatistician I in Bethesda, Maryland, to provide vital biostatistical support for clinical and laboratory research. This role involves performing statistical analyses on data from clinical trials and participating in projects that aim at advancing...
- The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Biostatistician I to provide statistical support for clinical and laboratory research under supervision. Work includes data analysis, reporting, and collaboration with cross-functional...
- ...professional and scientific services to the FDA Center for Devices and Radiological... ...analyzes IDEs, PMAs, 510(k)s, HDEs, Pre-Submissions, and other submissions for new technologies... ...services to assist the CDRH with their regulatory responsibilities. This candidate should...RegulatoryFor contractorsWork at officeRemote work
$110k - $130k
...Description: The Pharmacy Analyst supports the FDA's Office of Compounding Quality and... ...or similar data tracking systems in a regulatory or healthcare setting. Experience conducting... ..., third parties, or Corp-to-Corp submissions. Salary Range: ~$110,000-$130,000...RegulatoryPermanent employmentContract workWork at officeLocal area- ...LifeScience in Gaithersburg, MD seeks an experiencedClinical Regulatory Writing Associate Director to lead regulatory writing across a... ...communications and vendor collaboration. The role requires leading submission strategies (cSCS), mentoring teams, translating complex data...Regulatory
- ...systems Maintain compliance with all applicable clinical and regulatory standards throughout the duration of the assignment... ...license or Compact license — must be active and in hand at time of submission Current BLS certification — expiration date must be included...RegulatoryWeekly payFull timeContract workImmediate startMonday to FridayShift workDay shift
- ...Food Safety & Quality Assurance to lead commissary food safety plans, manage FDA registrations, and onboard suppliers across North America. This role emphasizes safeguarding consumers, regulatory compliance, and cross-functional collaboration. The position requires...Regulatory
$85k - $141k
...MD. Responsibilities:Design and generate expression constructs for viral proteins (e.g., envelope glycoproteins, capsid proteins, regulatory proteins). Develop and optimize expression systems (mammalian, insect, or stable cell lines). Purify proteins using...RegulatoryFull timeFlexible hours
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