[Remote] Biostatistician – Clinical Development & Evidence Generation

Note: The job is a remote job and is open to candidates in USA. K3 Innovations is seeking an experienced Biostatistician to support innovative clinical development and evidence generation initiatives within a leading pharmaceutical organization. This role focuses on analyzing clinical trial data and contributing to publication strategy and advanced statistical methodologies that support scientific and regulatory decision-making.

Responsibilities

• Provide statistical expertise supporting clinical trial data analyses across development programs
• Perform external comparator and synthetic control analyses
• Apply advanced statistical methodologies, including:
• Propensity Score Matching
• Causal Inference Methods
• Meta-Analyses
• External Control Analyses
• Support evidence generation strategies for clinical development programs
• Collaborate with cross-functional teams to develop statistical approaches that support scientific objectives
• Contribute to the preparation of:
• Scientific manuscripts
• Conference abstracts
• Publications
• Scientific presentations
• Support publication planning and execution with medical and clinical teams
• Interpret complex statistical findings and communicate results to both technical and non-technical stakeholders
• Ensure analyses are scientifically rigorous, reproducible, and aligned with industry best practices

Skills

• M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related quantitative discipline
• Experience supporting clinical trial data analysis within the pharmaceutical or biotechnology industry
• Strong knowledge of advanced statistical methodologies, including: External Comparator Analyses, Synthetic Control Methods, Propensity Score Matching, Meta-Analysis, Causal Inference
• Experience supporting scientific publications and evidence generation
• Excellent analytical, problem-solving, and communication skills
• Ability to collaborate effectively across Medical Affairs, Clinical Development, HEOR, Biostatistics, and cross-functional scientific teams
• Experience with Real-World Evidence (RWE) data generation
• Oncology or specialty pharmaceutical experience
• Experience supporting regulatory or payer evidence generation initiatives
• Strong statistical programming experience using SAS and/or R

Company Overview

K3-Innovations is redefining clinical research with a strategic scaling approach, blending AI-powered automation, adaptive clinical resourcing, and advanced data science. It was founded in 2013, and is headquartered in North Brunswick, New Jersey, USA, with a workforce of 51-200 employees. Its website is http://k3-innovations.com/.

Company H1B Sponsorship

K3-Innovations, Inc. has a track record of offering H1B sponsorships, with 2 in 2025, 2 in 2023, 3 in 2022, 3 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.