JOB DESCRIPTION:

Essential Duties Include, but are not limited to, the following:

• Ability to apply strong verbal, written, and graphical communication/presentation skills.

• Ability to work independently, prioritizing and producing high quality results.

• Ability to collaborate effectively as part of a cross-functional team.

• Maintain regular and reliable attendance.

• Ability to act with an inclusion mindset and model these behaviors for the organization.

• Under the direction of other statisticians, assist the biostatistical function on project-level work.

• Provide input into the design of analytical validity, clinical validity, clinical utility, health economics, and clinical experience studies by:

  • Evaluating evidentiary requirements.

  • Contributing to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans).

  • Reviewing case report forms and data transfer requirements.

  • Drafting statistical analysis plans.

• Apply standard statistical methodology and programming to:

  • Monitor laboratory and 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.

• Ability to regularly seek and integrate feedback from team members and managers in a professional manner.

• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

• Support and comply with the company’s Quality Management System policies and procedures.

• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.

• Ability to travel up to 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Master’s degree in Biostatistics or related field as outlined in the essential duties.

• Working knowledge of theoretical and applied statistics.

• Strong statistical programming skills (SAS, R, or Python).

• Basic computer skills to include internet navigation and email usage.

• Working knowledge of Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, OneNote, and Publisher.

• Demonstrated ability to perform the essential duties of the position with or without accommodation.

• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 2 years of relevant work experience.

• Experience in developing products for approval by regulatory authorities such as FDA.

• Experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: