Senior Biostatistician - Remote (US)

Senior Biostatistician

About MMS

• Join a company where your contributions truly matter.
• Proud of being a Great Place to Work certified organization.
• Supports pharmaceutical, biotech, and medical device industries with clinical research challenges.
• Global presence across four continents.
• Maintains industry-leading customer satisfaction rating.
• Fosters a collaborative and inclusive work environment.

Responsibilities

• Create randomization and kit schedules independently, collaborating with sponsor, randomization, and drug supply management teams.
• Develop phase 1-4 SAPs and contribute significantly to iSAPs. Create SAP TLFs shells for all phases and studies.
• Review ADAM and TLFs; work with clients and programmers to resolve comments.
• Strong programming and logic skills (working knowledge of SAS).
• Apply drug development knowledge during production of high-quality statistical analyses.
• Perform sample size calculations for various scenarios and study designs.
• Lead projects (all phases and even a program of studies), manage client meetings, CRMs, collaborate well with regulatory, PMs, and sponsor.
• Strong knowledge of CDISC (especially SDTM and ADaM), understands guidance from FDA in different therapeutic areas.
• Understand various tools used in the team.
• High-level knowledge of drug development as it pertains to biostatistics.
• Support 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 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.
• High proficiency with MS Office applications.
• Demonstrate an understanding of project management-related 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 in-house medical writers.

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 5 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; applies 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.
• 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 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.