Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Functions as the go-to statistical partner for Chemistry, Manufacturing, and Controls (CMC) activities, offering project-specific statistical strategies, hands-on data analysis, experimental design expertise, and method consultation. This role collaborates with cross-functional CMC teams—including process development, analytical development, manufacturing, and quality—to apply robust statistical methods that enhance product and process understanding and drive ongoing improvements. This role may also provide statistical support to nonclinical or clinical teams as bandwidth allows. 

• Identify & Apply Best-Practice Statistical Methods: Research and recommend/apply appropriate statistical methodologies for CMC projects, aligning with current regulatory guidelines and industry standards.
• Collaborate on DOE & Process Optimization: Partner with process development teams on design-of-experiments (DOE), propose design options, analyze data to inform process decisions, and provide statistical support for comparability assessments.
• Provide Consultative Input on Analytical Methods: Work with analytical development teams to incorporate statistical principles (e.g., DOE for method optimization, variance assessments) into method development, validation, transfer and troubleshooting.
• Support Stability Studies & Specification Rationale: Contribute to the planning and analysis of stability studies, performing or advising on statistical evaluations that help establish shelf-life and guide specification decisions made by relevant CMC teams.
• Recommend SPC Approaches for Ongoing Process Verification: Propose statistical process control (SPC) methods for manufacturing data monitoring, assist in setting control chart criteria, and support trend evaluation.
• Contribute to Regulatory Dossiers: Prepare and review statistical sections of regulatory submissions (e.g., IND, BLA, MAA), ensuring clarity, rigor, and alignment with applicable ICH and FDA/EMA guidelines.
• Mentor & Share Expertise: Provide guidance to other biostatisticians, statistical programmers, or scientists working on CMC tasks, fostering best statistical practices.
• Contribute to non-CMC Projects: Provide statistical consultation or hands-on support for nonclinical or clinical projects if bandwidth permits.

• Ph.D. or M.S. in Statistics or a related field.
• At least 8 years (12 years for M.S. degree) of experience in the pharmaceutical/biotech industry.
• Strong statistical expertise in experimental design, regression analysis, variance component analysis, multivariate analysis, nonlinear modeling, process capability, and control charts.
• Proficient in validation or transfer studies of analytical methods, specification calculations, comparability studies, product stability studies, optimization, and experimental design robustness evaluation.
• Broad knowledge of pharmaceutical development and CMC activities in a regulatory context, including good understanding of GMP activities and Quality by Design (QbD) framework.
• In-depth knowledge of FDA, EMA and ICH regulations and guidelines as they pertain to statistical aspects of CMC.
• Experience in NDA/BLA and/or MAA submissions (especially Module 3) and experience in addressing regulatory authorities questions.
• Proficient in statistical and programming software (e.g., SAS, R, JMP).
• Experience with cell or gene therapies is desirable but not required.
• Proven ability to use statistical simulations to account for uncertainty and in scenario planning for DOE and analyses.
• Strong organization skills and ability to concurrently work on multiple projects.
• Ability to effectively communicate statistical concepts and results to non-statisticians both in writing and verbally, providing consultative input and statistical insight.
• Ability to collaborate, communicate and interact effectively in a fast-paced team environment.

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.