Senior CMC Statistician

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 and applying innovative statistical techniques (e.g., Bayesian approaches, RShiny automation, classification model machine learning, bioinformatics, etc.), publishing in peer-reviewed journals, and representing Alnylam in external conferences. Statistics degree with 2+ years of relevant experience (PhD) or 5+ 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. Solid understanding of the statistical techniques theories foundational to carrying out the analyses and ICH guidance documents listed in Key Responsibilities. Familiarity with ICH guidance documents listed in Key Responsibilities is preferred. 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.