Senior Biostatistician

Summary

Join MMS, a leading data-focused CRO, and contribute to the development of life-changing therapies. As a Biostatistician, you will independently create randomization and kit schedules, collaborate with various teams, and develop statistical analysis plans (SAPs). You will review data and TLFs, ensuring high-quality statistical analyses. The role requires leading projects, managing client meetings, and collaborating with regulatory and project management teams. You will provide support to Data Safety Monitoring Boards (DSMBs) and contribute to the statistical sections of clinical study reports (CSRs). This position demands strong SAS programming skills, a deep understanding of CDISC standards, and extensive experience in biostatistics within the pharmaceutical industry.

Requirements

• 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
• 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
• 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 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
• Strong programming and logic skills (working knowledge of SAS)
• Ability to apply drug development knowledge during production of high quality statistical analyses
• 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
• High proficiency with MS Office applications

Responsibilities

• Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams
• Develop phase 1-4 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
• 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
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician
• Review the statistical section 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
• Create the statistical section of the Sponsor’s protocol with minimal support
• 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 in-house medical writers

Preferred Qualifications

• Experience in immunogenicity and serotype vaccine studies preferred
• Experience in pediatric studies preferred
• Thorough knowledge and understanding of clinical data preferred
• Hands-on experience with clinical trial and pharmaceutical development preferred