Description

Our client is seeking an experienced and curious statistical leader to join a science-driven organization dedicated to advancing patient access to innovative therapies. This role is based in Cambridge, Massachusetts and operates under a hybrid working model.

As Manager, Nonclinical Statistics, you will provide statistical direction and hands-on expertise across nonclinical research and development activities. You will partner closely with scientific and technical teams to apply modern statistical methodologies that improve experimental design, data interpretation, and evidence-based decision making throughout early development.

Your impact will span Chemistry, Manufacturing, and Controls (CMC) as well as discovery and translational science, including strong involvement in biomarker assay development and validation across preclinical and clinical settings.

What you will do

• Act as the primary statistical expert supporting nonclinical development initiatives
• Lead statistical strategy for analytical development and formulation work across multiple therapeutic modalities, including small molecules, biologics, and advanced therapies
• Provide statistical oversight for biomarker assay design, validation, and performance evaluation
• Partner with manufacturing, quality, and regulatory teams to embed data-driven approaches into development and control strategies
• Apply appropriate analytical techniques-including frequentist, Bayesian, and machine-learning approaches-tailored to diverse datasets and scientific questions
• Contribute as a core data science representative on cross-functional project teams
• Design experiments, define analysis plans, perform data quality checks, execute analyses, and produce clear, decision-ready outputs
• Expand internal analytics capabilities by introducing emerging methods and developing fit-for-purpose tools
• Collaborate within a matrixed environment to translate complex scientific problems into robust analytical solutions
• Support regulatory interactions by addressing statistical questions and documentation needs
• Identify risks related to data quality, resourcing, or timelines and escalate proactively
• Enhance the organization's external scientific profile through publications, conference participation, and external partnerships

What we're looking for Education & experience

• PhD in Statistics, Applied Mathematics, Computer Science, Engineering, or a related discipline
• or
• Master's degree with a minimum of 3 years of relevant applied experience
• Demonstrated experience in CMC activities and/or assay development and validation

Technical expertise

• Advanced proficiency in statistical programming languages such as R or Python
• Strong understanding of modern software development practices for analytical workflows
• Ability to independently manage complex datasets end to end, from raw data through final reporting

Professional skills

• Strong written and verbal communication skills, with the ability to explain technical concepts to non-statistical audiences
• Comfort working autonomously while collaborating effectively across disciplines
• Intellectual curiosity and willingness to rapidly build expertise in new scientific areas
• Familiarity with regulatory expectations (e.g., FDA, EMA, ICH) related to pharmaceutical development is advantageous

Work model

This role follows a hybrid structure, combining on-site collaboration with flexible remote work in alignment with organizational policy.

Compensation & benefits

The anticipated base salary range for this position is $111,800 - $175,670 USD, depending on qualifications, experience, and location. Final compensation will reflect individual skills, background, and applicable local requirements.

In addition to base pay, employees may be eligible for:

• Short- and long-term incentive programs
• Comprehensive medical, dental, and vision coverage
• Retirement savings plan with employer contribution
• Disability and life insurance coverage
• Paid time off, holidays, and sick leave
• Tuition assistance and professional development support
• Well-being programs and paid volunteer time