Senior Director, Biometrics

Summary

Join MMS, an award-winning CRO, and be part of a supportive, innovative team that values your contributions. We offer a Great Place to Work certified environment with exceptional culture and industry-best employee retention. As a remote, full-time employee, you will leverage your high-level knowledge of drug development biometrics to contribute to our work supporting pharmaceutical, biotech, and medical device industries. You will be a Subject Matter Expert, guiding others in biostatistical techniques and advising on industry trends. This role requires a strong understanding of regulations and the ability to define new solutions. We offer opportunities for professional growth and collaboration within a global team.

Requirements

• College graduate in statistics discipline or related field, masters or PhD preferred, or many years of related experience
• Minimum of 12 years’ experience in Biometrics or similar field required
• Ability to anticipate and effectively resolve potential problems with client demands
• Demonstrates managerial skill and experience
• Proficiency with MS Office applications
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skills

Responsibilities

• Has high level knowledge of drug development as it pertains to biometrics
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines
• Understands the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of Power BI for dashboard development or use of external SharePoint)
• High technical level, Subject Matter Expert in biometrics; willing to guide others in a variety of biostatistical techniques
• Proficient in the understanding of regulations and guidance as they pertain to data centric deliverables; mentors others and advises on MMS on industry trends and technologies
• Ability to define/bring new methods, tools and solutions to meet the needs of internal and external stakeholders and teams
• Proficient in conducting peer reviews for others and validation of project deliverables within the team
• Maintains a strong understanding of the latest industry trends and technologies with regard to Biometrics

Preferred Qualifications

• Hands-on experience with clinical trial and pharmaceutical development preferred
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process

Benefits

This would be a full-time role, working remotely