MMS
Principal Biostatistician - Remote (UK)
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Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-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 rate. We 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.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles And Responsibilities
- Lead complex projects, programs, and submissions, manage client meetings, CRMs, collaborate well with regulatory, PMs, and sponsors
- Can develop SAPs and iSAPs text and shells with no supervision
- Produce and present external 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 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
- 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
- Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)
- Provide support 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
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Requirements
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- 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)
- Has a high level of knowledge of drug development as it pertains to biostatistics
- Expert knowledge of scientific principles and concepts.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Good organizational skills
- High proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Excellent problem-solving skills.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements
- Good understanding of CROs and scientific & clinical data/terminology, & the drug development process
Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
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