Clinical Research Nurse enhancing pediatric oncology care at Monash Children's Hospital. Collaborating with medical staff and managing patient flow for effective cancer treatment.
About the role
- Clinical Biostatistician developing clinical evidence for molecular tests related to cancer screening and treatment at Exact Sciences. Collaborating with cross-functional teams while applying rigorous statistical methodologies.
Responsibilities
- Design clinical validity, clinical utility, health economics, and clinical experience studies.
- Evaluate evidentiary requirements.
- Contribute to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans).
- Review case report forms and data transfer requirements.
- Author statistical analysis plans.
- Apply rigorous statistical methodology and programming to:
- Monitor clinical data quality.
- Develop evidence for clinical predictive models in clinical studies and trials.
- Conduct simulation studies.
- Communicate statistical results in tables, figures, and listings; statistical analysis reports; clinical study reports; abstracts; manuscripts; regulatory submissions; presentations; and marketing collateral.
- Evaluate investigator sponsored study designs and analysis plans, evidence developed for external molecular tests, and applicability of novel statistical techniques.
Requirements
- Master’s degree in Biostatistics or field as outlined in the essential duties; or Bachelor's degree in Biostatistics or field as outlined in the essential duties, plus 2 years of experience in lieu of a Master’s degree.
- 4+ years of relevant work experience, as outlined in the essential duties.
- Demonstrated statistical experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare.
- Professional working knowledge of theoretical and applied statistics.
- Strong statistical programming skills (SAS, R, or Python).
- Strong verbal, written, and graphical communication/presentation skills.
- Proficiency with Microsoft Office programs, such as (Word, Excel, PowerPoint, Outlook, OneNote, etc.).
- Ability to work independently, prioritizing and producing high quality results.
- Ability to collaborate effectively as part of a cross-functional team.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Benefits
- Paid time off (including days for vacation, holidays, volunteering, and personal time)
- Paid leave for parents and caregivers
- Retirement savings plan
- Wellness support
- Health benefits including medical, prescription drug, dental, and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior Clinical Trial Manager overseeing site management and monitoring for biopharmaceutical solutions organization. Responsible for clinical monitoring, patient safety, and regulatory compliance in South Africa.
Associate HR Partner supporting employee operations at CPS Clinical Research Units. Providing HR guidance and managing employee relations in a clinical environment with on - site presence.
Clinical Research Study Assistant involved in Alzheimer's disease research collecting samples and data. Participating in study protocols and maintaining participant interactions.
Oncology Clinical Research Coordinator at WVU managing clinical trials and ensuring protocol compliance. Collaborating with research staff and healthcare providers while advocating for ethical participant care.
Clinical Research Coordinator supporting clinical research for pediatric care at Shriners Children’s. Ensuring compliance with research protocols and collaborating with clinical teams in Pasadena.
Clinical Research Coordinator managing aspects of clinical trials at Winship Cancer Institute. Handling data management, participant interface, and overseeing trial compliance in Atlanta.
Feasibility Manager at Novo Nordisk optimizing clinical trials through data analysis and strategic partnerships across South Africa. Driving site selection and operational readiness for impactful clinical development.
Clinical Research Coordinator managing overall coordination and implementation of clinical trials. Collaborating with investigators to ensure compliance with study protocols and maintaining accurate subject records.
Clinical Research Coordinator independently managing key aspects of clinical trials. Overseeing data management and ensuring compliance with study protocols and regulations.