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 biostatistics project. You will lead complex projects, collaborate with sponsors and regulatory teams, and provide statistical expertise throughout the drug development process. MMS fosters a collaborative and inclusive environment with a focus on employee growth and development. This role requires a Master's degree in Biostatistics or a related field, along with 7+ years of experience. The ideal candidate will possess strong leadership qualities and a deep understanding of statistical methodologies within the pharmaceutical industry.

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
• 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 various 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 preferred
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements