Biostatistician for Regulatory Submissions - Clinical Impact
Analysis Group
Analysis Group, Inc. is hiring a Biostatistician in Boston to support clinical trial analysis and decision-making. The successful candidate will apply biostatistical methods and manage analyst teams, with responsibilities in regulatory submissions and data integration. Preferred qualifications include an advanced degree in Biostatistics or a related field and 3–5 years of relevant experience in the biotech or pharma sectors. Competitive compensation and a comprehensive benefits package are offered. #J-18808-Ljbffr
$210k - $255k
...Access Practice:Make an impact at Analysis Group,... ...develop and implement regulatory and analytical... ...outcomes research (HEOR), clinical research, market access... ...firm).About the Biostatistician Position:Analysis Group... ...development, regulatory submissions (e.g., FDA, EMA), and...RegulatoryWork experience placementWork at officeLocal areaVisa sponsorship$123k - $163k
...Role: As a Principal Biostatistician, you will provide project... ...results, and prepare clinical study reports,... ...integrated summaries for submissions. Your role will also... ...Additionally, you will address regulatory issues and... ...contributions make a significant impact. Our team encompasses...RegulatoryFull timeTemporary workLocal areaWorldwide$203k - $247k
...Therapeutics? Entrada is a clinical-stage biopharmaceutical company... ...across teams to deliver impactful solutions.The OpportunityReporting... ..., clinical study reports, regulatory documentation and associated... ...development, regulatory submissions, and statistical practice.Strong...RegulatoryWork at officeLocal areaRemote work$103.7k - $124k
...About the Job: The Biostatistician I is responsible for... ...analyses, study reports and regulatory documents with high... ...in translational or clinical research. This role... ...of regulatory submissions and respond to review... ...employee can make an impact and continue to grow...RegulatoryFull timeInternship- ...Opportunity Prometrika is a full-service clinical research organization (CRO) with... ...summaries for New Drug Application (NDA) submissions Design analysis file specifications... ...junior level and new staff Understand regulatory requirements related to the specific...RegulatoryWork experience placement
$120.2k - $140k
...environment? As an experienced Clinical Data AMS Senior Consultant... ...posture of a suite of clinical and regulatory R&D platforms — including... ...statistical analysis and submission-ready outputs. The team follows... ...Deloitte’s purpose is to make an impact that matters for our people,...RegulatoryPermanent employmentLocal areaRemote workVisa sponsorship$110k
A biostatistician applies statistical methods to health research designing... ...advancing medical research, clinical trials, epidemiology, and... ...and analyzing data to support regulatory approvals. Academic... ...environmental exposures and their impact on public health. Technological...RegulatoryWork at officeWorldwide$184.54k - $276.81k
...R&D, bridging discovery and regulatory toxicology. You will develop... ...toxicology expertise to anticipate clinical safety risks and provide... ...contribute to regulatory submissions. Provide regulatory and scientific... ...meets innovation to create impactful solutions! We challenge the...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week- ...powering the acceleration of clinical research to transform... ...employees world-wide.As a Clinical Regulatory Specialist at Iterative... ...environment.Where You’ll Drive Impact Support Regulatory Activities... ...and coordinate initial IRB submissions, amendments, continuing reviews...RegulatoryTemporary workWork at office2 days per week
$119.7k - $222.3k
...search of a Principal or Senior Principal Biostatistician to join a passionate team in early... ...operational, in collaboration with the clinical trial teams and other quantitative partners... ....Collaborate with clinical, regulatory and other strategic functions to drive...RegulatoryFull timeRelocation package- ...powering the acceleration of clinical research to transform... ...world-wide.As a Senior Clinical Regulatory Specialist at Iterative Health... ...environment.Where You’ll Drive Impact Regulatory Operations &... ...regulatory documentation and submissions for completeness, accuracy,...RegulatoryTemporary workWork at office2 days per week
$164k - $199k
...discipline, with 8+ years of clinical operations experience, including... ...and working knowledge of regulatory guidelines/directives.Proficiency... ...Study Reports and Regulatory submission documentsConduct on-going... ...effectively and achieve meaningful impact.Compensation:The stated base...RegulatoryContract workLocal area$253.33k - $286.67k
...drive the advancement of our clinical programs while upholding our... ...and escalate issues that could impact timelines or budgets.... ...locations and sites globally. Regulatory Support: Contribute to global clinical and regulatory submissions. Stakeholder Engagement:...RegulatoryFull time$148k - $236.5k
...Associate Director or Director, Clinical Development Operations to... ..., data management, regulatory affairs, and quality.Lead or... ...DSMB preparations, IND/CTA submissions, and other key regulatory and... ...positive social and environmental impact through activities that are...RegulatoryFor contractors$190.8k - $300.3k
Job DescriptionThe Senior Director, Clinical Science - Lung is responsible for providing... ...with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management... ....Experience contributing to regulatory submissions, safety reviews, or health authority interactions...RegulatoryFull timeFor contractorsLocal areaFlexible hours$75k - $80k
...vary across patient-level clinical trial data, observational study... ...technology assessment submissions. You will therefore be exposed... ...A Day in the Life of a Biostatistician To learn more about a typical... ...transformed into fulfilling, impactful careers with us. Learn more...Permanent employmentFull timeTemporary workWork at officeWork from homeFlexible hours$169.1k - $314k
...and help productize solutions to deliver impact in close partnership with internal Roche... ...that unlock actionable insights from clinical, operational, and real-world data. With... ...practicesFamiliarity with data governance, privacy, and regulatory frameworks relevant to ML in...RegulatoryFull timeTemporary workLocal area- Mass General Brigham Biostatistics seeks a Biostatistician I to join a team supporting clinical research across multiple divisions. You will collaborate with physicians and life scientists to design studies and perform robust data analyses. Responsibilities include planning...
- ...AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical pharmacology initiatives for CNS... ...drug development processes and regulatory compliance.Provides subject matter... ...pharmacology components of regulatory submissions and health authority interactions.Promotes...Regulatory
$252k - $269k
Clinical Quality Assurance Senior Leader provides strategic leadership... ...and respond to evolving regulatory expectations. Strategic Leadership... .... Assess audit findings for impact on subject safety, data... ...protocols, IBs, NDAs, and other submission related materials. Risk...RegulatoryLocal areaWorldwide- ...decisions at the study level across various studies, leading and prioritizing tasks globally Collaborate closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines Monitor needs and determine resources in consultation...RegulatoryWorldwide
$130k - $190k
...a motivated and experienced Clinical Data Management professional... ...Statistical Programming, Medical, Regulatory, and external partners to... ...reports, and regulatory submissions.Track and communicate study-... ...quality concerns, and timeline impacts with recommended mitigation...RegulatoryFull timeInterim role$171.2k - $256.8k
...assurance oversight across clinical and nonclinical programs to... ...compliance with GCP, GLP, and global regulatory requirements. This role... ...regulatory inspections and submissions, and provide strategic QA... ...readyOversee quality events impacting GCP/GLP (e.g., serious breaches...RegulatoryContract work- ...success for our clients and advancing clinical research projects. As a part of the Global... ...organization, your work has a direct impact on the projects, teams, and clients... ...clinical development process through regulatory submissions. Additional years of experience will be...RegulatoryRemote work
- ...Vice President of Clinical Pharmacology About the Company... ...strategic input for NDA/MAA submissions, and contributing to the interpretation... ...pharmacology sections for regulatory submissions, as well as... ...communication skills. This is a high-impact leadership role that offers...Regulatory
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma...Regulatory
$160k - $275k
Who we are:Kymera is a clinical-stage biotechnology company pioneering... ...heard.How you’ll make an impact:Serve as the study level... ...integrity and alignment with regulatory standards. Collaborate with... ....Support IRB and regulatory submissions and query responses.Present...Regulatory$170k - $220k
...bodies and daily lives.As a Staff Clinical Scientist, you will serve as... ...’s most complex and high-impact health initiatives. You will... ...exploration through validation and regulatory evidence generation,... ...evidence summaries, regulatory submission sections, manuscripts, abstracts...RegulatoryFull timeWork at officeRelocation- Reportingto:Sr. Director,Clinical Data Management Do you have the passion and commitment... ...that have a clear and profound impact on patients suffering from rare diseases... ...quality and inspection readiness, support regulatory submissions, and ensure the timely delivery of...Regulatory2 days per week
$102k - $145k
The Opportunity:As Clinical Project Manager, you will be accountable... ...’s innovative science into impactful medicines for patients.The... ...CROs on site selection, IRB/EC submissions and queries, site initiation... ...compliance with required regulatory and ICH GCP quality standards...RegulatoryContract work
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