FULL_TIME

FEED

OTHER

We deliver care across six states through two freestanding children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida - along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships. This hybrid role focuses on collaboration with researchers in the North Florida (Jacksonville) region, working alongside clinical investigators, physicians, and scientists in multidisciplinary research environments.

Nemours is seeking a Biostatistician to join our Nemours Children's Health team in Jacksonville, FL.Position Title: Biostatistician Location: Hybrid based in Jacksonville, FL Department: Biomedical Research Informatics Center (BRIC) Reports To: Manager, Research BiostatisticsOverview: The Biostatistician is a critical contributor to the Biomedical Research Informatics Center (BRIC), providing essential support as part of the Biostatistical Core. This hybrid role focuses on collaboration with researchers in the North Florida (Jacksonville) region, working alongside clinical investigators, physicians, and scientists in multidisciplinary research environments. This position requires a minimum of 3 years of post-Master's degree experience as a statistician/biostatistician.Key Responsibilities: <ul><li>Assist with the design of clinical, epidemiological, and basic science research studies</li><li>Draft statistical analysis plans for research proposals and grant applications</li><li>Perform sample size calculations and power analyses</li><li>Manage, analyze, and interpret complex clinical datasets</li><li>Prepare statistical results for study reports, publications, and presentations</li></ul> Why Join Us? This is an exciting opportunity to contribute to impactful pediatric health research in a dynamic and collaborative setting. The Biostatistician will play a pivotal role in advancing scientific discovery and improving health outcomes for children through support of diverse clinical studies.Qualifications: <ul><li>Master's degree in Biostatistics, Statistics, Data Science, or a related field (required)</li><li>Minimum of 3 years of post-Master's degree experience as a statistician/biostatistician</li><li>Proficiency in statistical and data science software (e.g., R, SAS, Python)</li><li>Experience with health-related data and familiarity with clinical and biomedical research</li><li>Strong project management skills with the ability to prioritize tasks, meet deadlines, and work independently while fostering team collaboration</li><li>Effective technical communication, including writing, presenting, and documenting code</li></ul> Preferred Experience: <ul><li>Pediatric research</li></ul>About Us Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida - along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships.Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child thrive.Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued.Learn more at Nemours.org .

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Nemours

Biostatistician

Analysis Skills

Bid Analysis

Biomedical Research

Biostatistics

Clinical Research

Clinical Support

Clinical Trial

Communication Skills

Data Science

Data Sets

Documentation

Drug Development

Establish Priorities

Grant Writing

Hospital

Informatics

Pediatrics

Project/Program Management

Publications

Python Programming/Scripting Language

R Programming Language

Research Grants

Science Software

Scientific Research

Statistical Analysis System (SAS)

Statistics

Team Player

Time Management

Urgent Care

equestftpin

YEAR

Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.

About MMSAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com" rel="nofollow">www.mmsholdings.com</a> or follow MMS on <a href="https://www.linkedin.com/company/mms-holdings-inc-" rel="nofollow">LinkedIn</a>.Senior Biostatistician:Responsibilities: <ul><li>Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.</li><li>Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.</li><li>Review ADAM and TLFs; work with client and programmers to resolve comments.</li><li>Strong programming and logic skills (working knowledge of SAS)</li><li>Ability to apply drug development knowledge during production of high quality statistical analyses.</li><li>Perform sample size calculations for a variety of scenarios and study designs.</li><li>Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.</li><li>Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas. </li><li>Understand the various tools that we work with</li><li>High level knowledge of drug development as it pertains to biostatistics.</li><li>Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.</li><li>Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support</li><li>High proficiency with MS Office applications</li><li>Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.</li><li>Provide ICH guideline based input as applicable to statistics.</li><li>Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.</li></ul>Requirements:<ul><li>College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.</li><li>Minimum of 5 years’ experience in Biostatistics or similar field required.</li><li>Expert knowledge of scientific principles and concepts. </li><li>Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.</li><li>Strong SAS programming, SAS base, SAS macro experience.</li><li>Thorough knowledge and understanding of clinical data preferred.</li><li>Strong experience with data and production of TLGs.</li><li>Excellent scientific writing skills.</li><li>Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.</li><li>Proficiency with MS Office applications.</li><li>Hands-on experience with clinical trial and pharmaceutical development preferred.</li><li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.</li><li>Excellent problem-solving skills.</li><li>Good organizational and communication skills.</li><li>Familiarity with 21 CFR Part 11, FDA, and GCP requirements.</li><li>Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.</li></ul>Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.Powered by JazzHR

Senior Biostatistician - Remote (US)

Accreditation Standards

Biotech and Pharmaceutical

Clinical Data

Clinical Data Interchange Standards Consortium (CDISC)

Code of Federal Regulations

Computer Programming

Contract Research Organization (CRO)

Customer Relationship Management (CRM) Systems

Customer Satisfaction

Employee Retention

FDA (Food and Drug Administration)

FDA Requirements

GCP (Good Clinical Practices)

ICH Regulations

LinkedIn

Mathematics

Medical Equipment

Medical Writing

Microsoft Office

Needs Assessment

Organizational Skills

Problem Solving Skills

Project Estimates

Regulations

Regulatory Submissions

Sales Management

Scientific Principles

Vendor/Supplier Management

Wireless Multimedia Messaging Service

Writing Skills

partner JazzHR

Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction. Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.   Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com/" rel="nofollow">www.mmsholdings.com</a> or follow MMS on <a href="https://www.linkedin.com/company/mms-holdings-inc-" rel="nofollow">LinkedIn</a>.Roles and Responsibilities<ul><li>Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors.</li><li>Can develop SAPs and iSAPs text and shells with no supervision.</li><li>Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction.</li><li>Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments.</li><li>High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques.</li><li>Has the ability to apply drug development knowledge during production of complex statistical analyses.</li><li>Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study.</li><li>Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers.</li><li>Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management.</li><li>Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations.</li><li>Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.</li><li>Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint).</li><li>Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.</li><li>Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.</li><li>Write blogs and/or white papers for posting on the company website.</li></ul><div>Requirements<ul><li>Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred.</li><li>Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required.</li><li>Submission experience (ISS/ISE).</li><li>Has high level knowledge of drug development as it pertains to biostatistics.</li><li>Expert knowledge of scientific principles and concepts. </li><li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.  </li><li>Good organizational skills.</li><li>High proficiency with MS Office applications.        </li><li>Hands-on experience with clinical trial and pharmaceutical development preferred.</li><li>Excellent problem-solving skills.        </li><li>Familiarity with current ISO 9001 and ISO 27001 standards preferred.            </li><li>Familiarity with 21 CFR Part 11, FDA, and GCP requirements.</li><li>Good understanding of CROs and scientific & clinical data/terminology, & the drug development process.</li></ul></div>Powered by JazzHR

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Biostatistician Nemours

Senior Biostatistician - Remote (US) MMS

Principal Biostatistician - Remote MMS

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