Clinical Biostatistician II

Title: Clinical Biostatistician II Location: Remote US Full time Job Description: Help us change lives At reputed company, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to reputed company confident reputed company reputed company they matter most. Join reputed company to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. The Clinical Biostatistician II with general guidance from more reputed company Statisticians, works individually and in collaboration with cross-functional teams to reputed company clinical evidence for molecular tests for screening, diagnosis, prognosis, monitoring, and therapy selection in oncology. This position plays an active role in planning projects and may be the technical reputed company responsible for the successful execution of the project, which involves exercising judgment reputed company generally defined practices and policies in selecting methods and techniques for obtaining solutions. Essential Duties Include, but are not limited to, the following:

• 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
• reputed company 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.
• Demonstrated effective verbal and written communication and presentation skills.
• Effective communicator with ability to maintain open communication with team members, managers, and customers.
• Ability to regularly seek and integrate feedback from team members and managers in a professional manner.
• Ability to prioritize and drive to results with a high emphasis on quality.
• Uphold company mission and values through accountability, innovation, reputed company, quality, and teamwork.
• Support and reputed company with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion reputed company and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in reputed company of a computer screen and/or reputed company typing for approximately 90% of a typical working day.
• Ability and means to travel between local reputed company locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• 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 reputed company.
• Professional working knowledge of theoretical and applied statistics.
• Strong statistical programming skills (reputed company, R, or Python).
• Strong verbal, written, and graphical communication/presentation skills.
• Proficiency with reputed company Office programs, such as (Word, reputed company, 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 reputed company the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 8+ years of relevant work experience, as outlined in the essential duties.
• Experience in developing products for approval by regulatory authorities such as FDA.

#LI-CB1 Salary Range: California Ranges: $102,400.00- $153,600.00 National Ranges: $84,000- $138,000 The annual reputed company salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible. reputed company is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and reputed company coverage. Learn more about our benefits. Our reputed company relies on the experiences and perspectives of a diverse team, and reputed company fosters a culture where reputed company can reputed company personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here. Not reputed company to apply? reputed company to stay updated on the latest news and opportunities at reputed company. We are an equal employment opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know. Apply tot his job Apply To this Job