Statistician (Scientist I)

Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose-driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us. If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. About The Role The Scientist I (Statistics) supports the application of statistical methods to bioanalytical assay development, qualification, and validation activities within the Quality Control and Analytical Development functions. This role applies established statistical approaches to ensure data integrity, regulatory compliance, and accurate interpretation of analytical results. The Scientist I collaborates cross-functionally to support experimental design, data analysis, and documentation, contributing to the advancement of gene therapy programs. What You'll Do: · Apply established statistical methods to support development, qualification, and validation of bioanalytical methods (e.g., potency assays, ddPCR workflows) · Perform statistical analyses for assay validation, including linearity, accuracy, precision, and detection limits · Support stability studies through trend analysis, control charting, and regression modeling · Assist in data review, interpretation, and troubleshooting for assay development and optimization activities · Contribute to statistical analysis plans (SAPs), validation protocols, technical reports, and regulatory documentation · Collaborate with cross-functional teams (QC, Analytical Development, Process Development, Regulatory) · Support investigations, deviations, and root cause analyses with statistical input · Assist in developing and maintaining data trending and reporting tools · Ensure compliance with regulatory requirements (e.g., ICH, USP, FDA) · Communicate statistical findings clearly to stakeholders What You'll Bring: • Ph.D. in Statistics or related field (or Master’s with relevant experience) • 1–3 years of relevant experience in a biopharmaceutical, biotechnology, or analytical laboratory setting • Experience with statistical software (JMP, SAS, R, Python) • Strong analytical and problem-solving skills • Effective written and verbal communication skills • Ability to work independently within defined frameworks and collaborate across teams Preferred Skills • Familiarity with nucleic acid-based assays (e.g., ddPCR, qPCR) • Experience with protein or cell-based assays (e.g., ELISA, flow cytometry) • Experience in GxP-regulated environments • Exposure to assay validation and stability studies This job description is not designed to cover or contain a c…