K3-Innovations, Inc. · 2 hours ago
CMC Biostatistician – Translational & Early Development (TED)
Greater Boston
Full-time
Onsite
Mid LevelK3-Innovations, Inc. is seeking a CMC Biostatistician to join their Translational and Early Development team within Global Biostatistical Sciences. In this role, you will provide statistical expertise across early-stage R&D, focusing on pre-clinical development, CMC, biological assays, and biomarker research.
Health CareMedicalMedical DevicePharmaceutical
Hiring Manager
Ilene Brooks
Responsibilities
Provide statistical support for early-stage vaccine R&D programs, including:
Pre-clinical studies
CMC-related activities
Biological assay development
Biomarker research and analysis
Partner closely with scientists, project managers, and cross-functional teams to support study design, data analysis, and interpretation
Collaborate with senior managers within the TED team to ensure alignment with scientific and development objectives
Contribute to statistical strategies that support translational research and early development milestones
Support high-quality, compliant statistical deliverables aligned with global R&D standards
Qualification
Required
Degree in Statistics, Biostatistics, Mathematics, or a related scientific field
Experience providing statistical support in R&D, pre-clinical research, CMC, bioassays, and/or biomarker studies
Ability to work collaboratively in a cross-functional, scientific environment
Strong communication skills with the ability to translate statistical concepts to non-statistical stakeholders
Preferred
Understanding of vaccine development or biologics development strongly preferred
Company
K3-Innovations, Inc.
K3-Innovations is redefining clinical research with a strategic scaling approach, blending AI-powered automation, adaptive clinical resourcing, and advanced data science.
Founded in 2013
51-200 employees
H1B Sponsorship
K3-Innovations, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (3)
2021 (3)
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase