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, 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
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 comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Work Environment and Physical Demands This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.
We've Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- 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.
Rewarding your impact- 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.
Your wellness, supported- 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.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
