Contract Biostatistician- REMOTE EST

Orbis Clinical is seeking a remote-based Contract Biostatistician for 6 months. Title: Contract Biostatistician Contract duration: Initial 6-months with opportunity to extendLocation: client based in MA but worker can be remote based. EST time zone preferred.SummaryThe Contract Biostatistician will be a key member of clinical study teams responsible for the development and conduct of statistical analyses contributing to publications and presentations arising from company-sponsored clinical studies. Responsibilities will include participating in study design, selecting appropriate and innovative statistical methods, conducting analyses, interpreting data, and reporting preliminary and final study results. The ideal candidate is a strong communicator who is highly motivated, energetic, and forward-thinking.ResponsibilitiesBe accountable for all statistical aspects of protocols and regulatory submissions for assigned clinical studies.Work with Clinical, Pharmacovigilance, and Regulatory personnel in the preparation of statistical documents, including Statistical Analysis Plans (SAPs), and analyses such as safety and efficacy analyses to support:DSMB/DMC meetingsDevelopment Safety Update Reports (DSURs)Investigator BrochuresWork with Data Management personnel in the preparation of high-quality datasets in usable formats.Collaborate with Medical Writing personnel in the preparation of Clinical Study Reports and other regulatory documents, including NDA submissions.Work with Publications and Data Analytics personnel in the preparation of meeting abstracts, presentations, and analytical reports of preliminary data from ongoing clinical studies.Proactively mentor and train team members to continually improve processes and procedures in support of internal and external customers.Guide teams in the design and analysis of clinical studies using appropriate and innovative statistical methods.Review draft presentations and training materials, including posters and slide decks, according to established deadlines.QualificationsM.S. or Ph.D. in Statistics, Applied Mathematics, or a related quantitative field.Demonstrated ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review, and reporting of results across multiple studies and projects.Practical experience applying advanced statistical methodologies to clinical trial design and analysis.Experience supporting regulatory reporting and submissions.Strong analytical skills with demonstrated experience gathering, interpreting, and analyzing data in clinical research and drug development.Strong written and verbal communication skills.Ability to clearly communicate statistical information to non-statisticians and willingness to educate internal team members.Ability to work effectively in a fast-paced environment.Compensation Details:Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.The Pay Range for this position is $95 - $110 per hour, can vary depending on employment status.Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).  EEO and Reasonable Accommodation Statement:Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.