Experienced Biostatistics Consultant - Remote

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 a 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.

This would be a consulting opportunity in Biostatistics supporting a project that would have a 35-40 hour per week workload. 

Roles and Responsibilities:

• Serve as study statistician for the assigned study(ies).
• Can create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams. 
• Provide input in study design, sample size and statistical methodologies.
• Can develop SAPs and iSAPs text and shells with no supervision.
• Can review/validate ADaM and SDTM specifications and files created by CRO from the raw data; can work with programmers and junior statisticians to resolve comments.
• Can review/validate SDRG and ADRG and define files for the SDTM and ADaM data.
• Review Protocol Synopsis, Protocol and SAP.
• 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.
• 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.
• Provide statistical expertise as needed.

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.
• Expert knowledge of scientific principles and concepts. 
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.        
• Hands-on 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 problem-solving skills.        
• Good organizational and communication skills.          
• 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 and clinical data/ terminology, and the drug development process.