Principal Biostatistician

Summary

Join MMS, an award-winning, data-focused CRO, and be part of a supportive, innovative team that values its employees. We offer a collaborative and inclusive work environment with a global footprint. As a Principal Biostatistician, you will lead complex projects, collaborate with sponsors and internal teams, and contribute to the future of clinical research. You will leverage your expertise in biostatistics to guide others, perform complex analyses, and ensure regulatory compliance. The role involves client interaction, presentation of findings, and contribution to company publications. MMS is committed to providing a positive work environment and fostering professional growth.

Requirements

• Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred
• Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required
• Submission experience (ISS/ISE)
• Expert knowledge of scientific principles and concepts
• Reputation as emerging leader in field with sustained performance and accomplishment
• 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

• Can create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams
• Can develop SAPs and iSAPs text and shells with no supervision
• Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments
• High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques
• Has the ability to apply drug development knowledge during production of complex statistical analyses
• Can perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations
• Leads complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor
• 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 external SharePoint)
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician
• Has high level knowledge of drug development as it pertains to biostatistics
• Produces and presents external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction
• Write blogs and/or white papers for posting on the company website
• Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study
• High proficiency with MS Office applications
• Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management
• Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers

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