Statistician (Scientist I)

Forge Biologics•Columbus, OH

11d•Onsite

About The Position

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.

Requirements

Ph.D. in Statistics, Bioinformatics, 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

Nice To Haves

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

Responsibilities

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

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.
Annual bonus opportunities for all full-time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage to protect your peace of mind.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.