Biostatistics Consultant

Summary

Join MMS, an award-winning CRO, and become a Study Statistician contributing to impactful clinical research. This consulting opportunity offers a 35-40 hour per week workload supporting a project. You will serve as the study statistician, creating randomization schedules, collaborating with sponsors, and providing input on study design. Responsibilities include developing SAPs and iSAPs, reviewing data specifications, and providing statistical consulting. You will lead complex projects, manage client meetings, and stay current with industry practices. MMS fosters a collaborative and inclusive work environment.

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
• 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
• Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process

Responsibilities

• Serve as study statistician for the assigned study(ies)
• 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
• Develop SAPs and iSAPs text and shells with no supervision
• Review/validate ADaM and SDTM specifications and files created by CRO from the raw data; work with programmers and junior statisticians to resolve comments
• Review/validate SDRG and ADRG and define files for the SDTM and ADaM data
• Review Protocol Synopsis, Protocol and SAP
• Guide others in a variety of biostatistical techniques
• Apply drug development knowledge during production of complex statistical analyses
• Perform sample size calculations for a variety of scenarios and study designs. Provide statistical consulting support to sponsors re study design and sample size calculations
• Lead complex projects, programs and submissions, manage client meetings, CRMs, collaborate well with regulatory, PMs and sponsor
• Stay current with the latest industry practices and updated regulatory guidelines
• Use tools 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
• 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
• Demonstrate 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

Preferred Qualifications

• Hands-on experience with clinical trial and pharmaceutical development
• Familiarity with current ISO 9001 and ISO 27001 standards
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements