Senior Biostatistician

About MMS

MMS is an innovative datafocused CRO that supports the pharmaceutical biotech and medical device industries with a proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver highquality service and technology solutions rooted in strong science and decades of regulatory experience that will assist our clients in developing and marketing lifechanging therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS enthusiasm collaboration and teamwork are fostered knowing that a global and diverse talent pool makes the company more information follow MMS onLinkedIn.

• Create randomization and kit schedules independently collaborate with sponsor randomization and drug supply management teams.
• Develop phase 14 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.
• Review ADAM and TLFs; work with client and programmers to resolve comments.
• Strong programming and logic skills (working knowledge of SAS)
• Ability to apply drug development knowledge during production of high quality statistical analyses.
• Perform sample size calculations for a variety of scenarios and study designs.
• Leads projects (all phases and even a program of studies) and smaller submissions manages client meetings CRMs collaborates well with regulatory PMs and sponsor.
• Strong knowledge of CDISC (especially SDTM and ADaM) looks to understand guidance from FDA from the different therapeutical areas.
• Understand the various tools that we work with
• High level knowledge of drug development as it pertains to biostatistics.
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Review the statistical section 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. Create the statistical section of the Sponsors protocol with minimal support
• High proficiency with MS Office applications
• Demonstrate an understanding of project managementrelated tasks such as timelines scope and resource requirement estimation.
• Provide ICH guideline based input as applicable to statistics.
• Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with inhouse medical writers.

• Experience in immunogenicity and serotype vaccine studies preferred
• Experience in pediatric studies preferred
• College graduate in Biostatistics Statistics or Mathematics discipline or related field masters or PhD preferred or many years of related experience required.
• Minimum of 7 years experience in Biostatistics or similar field required.
• Expert knowledge of scientific principles and concepts.
• Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.
• Strong SAS programming SAS base SAS macro experience.
• Thorough knowledge and understanding of clinical data preferred.
• Strong experience with data and production of TLGs.
• Excellent scientific writing skills.
• Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.
• Proficiency with MS Office applications.
• Handson experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problemsolving skills.
• Good organizational and communication skills.
• Familiarity with 21 CFR Part 11 FDA and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology & the drug development process.