CMC Statistician Intern

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.  

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com.

Location: Cambridge, MA

Engagement: Internship (Full Time, Summer)

Level: Undergraduate (Junior or Senior)

Prime Medicine is a genetic medicines company developing a new class of one-time curative therapies using prime editing, a precise gene editing technology capable of correcting virtually any type of mutation without cutting both strands of DNA. Our pipeline spans multiple therapeutic areas, and our CMC organization plays a central role in translating scientific breakthroughs into medicines that meet the rigorous standards required for clinical development.

This internship places you inside Prime Medicine's CMC function at a moment when our programs are advancing toward and through clinical development. You will contribute real statistical support across analytical method validation, process characterization, stability analysis, and specification setting to provide the quantitative backbone of any CMC package.

This is hands-on work. You will analyze real data from real programs, interact with scientists and CMC colleagues to understand the questions behind the numbers, and produce outputs that directly inform development decisions. A strong working knowledge of applied statistics and genuine curiosity about biopharmaceutical development are the two things that matter most.

• Apply statistical methods (including design of experiments, DoE) to support method development, qualification and validation activities, including assessments of accuracy, precision, linearity, range, and robustness.
• Summarize and interpret data in a manner suitable for inclusion in regulatory-facing documentation.

• Support statistical analysis of process development data to identify critical process parameters and understand sources of variability.
• Contribute to DoE planning and analysis in collaboration with process development scientists.

• Analyze stability data using ICH-aligned statistical approaches, including regression modeling and degradation rate estimation.
• Contribute to the development and maintenance of statistical process control (SPC) techniques for monitoring reference standard and critical reagent performance.
• Support shelf-life and retest period calculations and help maintain stability tracking tools.

• Apply statistical methods to support specification setting for drug substance and drug product, including tolerance interval calculations and acceptance criteria justification.
• Assist in statistical review of release and characterization data across development-stage lots.

• Prepare clear, well-documented statistical analyses suitable for inclusion in technical reports, regulatory submissions, and IND-enabling packages.
• Work within a GxP-aware environment; gain practical exposure to documentation standards and data integrity principles relevant to early-phase pharmaceutical development.

• Enrollment in a BS program in Statistics, Biostatistics, Mathematics, Chemical Engineering, or a related quantitative discipline; junior or senior standing preferred.
• Solid foundation in applied statistics, including regression, hypothesis testing, variance analysis, and tolerance or confidence intervals.
• Proficiency in at least one statistical computing environment (R, Python, JMP, or Minitab).
• Ability to communicate quantitative results clearly, both in writing and in conversation with scientific collaborators.

• Coursework or project experience in experimental design (DOE) or statistical process control.
• Familiarity with ICH guidelines relevant to CMC statistics (e.g., Q2(R2), Q8, Q1E).
• Prior lab, co-op, or research experience in a pharmaceutical, biotech, or academic drug development setting.
• Exposure to GxP environments or data integrity principles, even in an academic or co-op context.

Most statistics internships keep interns at arm's length from the decisions that matter. This one does not. Prime Medicine is a focused company building programs from the ground up, which means the work you do this summer will be visible, consequential, and connected to people who can explain why it matters. You will leave with a clear understanding of how statistics functions inside a GxP-facing CMC organization, and with work product you can speak to directly.