Principal Biostatistician

Are you looking to join a company where your contributions truly matter and where youll be part of a supportive innovative teamMMS is anaward-winning data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization recognized for our exceptional culture and industry best employee retention support the pharmaceutical biotech and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

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Roles and Responsibilities

• Leadcomplex projects programs and submissions manages client meetings CRMs collaborates well with regulatory PMs and sponsors.
• Can develop SAPs and iSAPs text and shells with no supervision.
• Produceand presentexternal company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction.
• 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.
• Review or create the statistical section(s) of a Sponsors 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.
• Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers.
• Demonstrate an understanding of project management-related tasks such as timelines scope and resource requirement estimation/management.
• 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.
• Ability to create randomization and kit schedules independently collaborate with sponsor randomization and drug supply management teams.
• Understandthe various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint).
• Providesupport to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Write blogs and/or white papers for posting on the company website.