Principal Statistician

This role is considered On-Site.

Overview

The Principal Statistician will be a member of the Statistics team in the Chemistry, Manufacturing, and Controls (CMC) department. The Principal Statistician will apply statistical techniques in partnership with multidisciplinary teams to advance Alnylam’s RNAi therapeutics and will consult with internal stakeholders to prescribe fit-for-purpose statistical methodologies. In addition, this position will set statistical direction through educating and standardizing statistical practices into SOP’s and guidance documents.

This position is onsite and will be primarily located at our 675 W Kendall office in Cambridge, MA. 

Key Responsibilities

• Partner with synthetic chemists and engineers to develop control strategies per ICH Q8 through application of Design of Experiments (DOE) and Quality by Design (QbD) principles for process development and characterization.
• Support analytical chemists to characterize and validate fit-for-purpose assays per ICH Q2 and Q14 using regression, variance component analyses, DOE, etc.
• Support stability scientists to establish retest period and shelf-life through application of analysis of covariance (ANCOVA) per ICH Q1E and other innovative alternatives.
• Work with a matrixed team to justify drug substance and product specifications per ICH Q6A through analysis of batch data using random and linear mixed effects models to construct applicable statistical intervals.
• Equip QC and manufacturing stakeholders with Statistical Process Control (SPC), Capability Analysis, and Out-of-Trend (OOT) detection tools to improve product quality.
• Employ data mining to synthesize process knowledge into platform approach through predictive models.
• Author statistical SOP’s and guidance documents, sections of technical reports and regulatory submissions.
• Develop and deliver seminar workshops to promote statistical literacy and equip partners with statistical tools.
• Keep up with developments in statistical trends through researching innovative statistical techniques (e.g., Bayesian approaches, RShiny automation, etc.), publishing in peer-reviewed journals, and representing Alnylam in external conferences.

Qualifications

• Statistics degree with 5+ years of relevant experience (PhD) or 10+ years (MS) of relevant experience in bio/pharmaceutical industry.
  • Alternatively, primary degrees in Chemistry, Chemical Engineering, or life sciences with significant statistical training through courses and work experience may be considered.
• Demonstrated experience in most of the statistical techniques and ICH guidance documents listed in Key Responsibilities.
• Proficiency in R programming language.
• Fluency in JMP or Minitab.
• Effective oral and interpersonal communication skills to consult partners for project background and to influence technical team on statistical direction to take.
• Excellent written communication skills as demonstrated in authorship of peer-reviewed publications and of statistical sections in technical reports and regulatory submissions.

#LI-Onsite

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.