Global Biologics Pharmaceutical company here in the Cambridge, MA Area seeking a Sr. Biostatistician to join their team! This role will serve as the Statistician for their cGMP Manufacturing site and responsible for providing statistical support and guidance to the site. The ideal candidate will demonstrate solid understanding and use of statistical principles and practices to solve a range of complex problems in order to improve manufacturing success rates in real-time, provide retrospective data analysis for process improvements, and provide input for complex manufacturing investigations. The candidate should also demonstrate the ability to successfully perform complex statistical data analysis independently. Position responsibilities include:
* Provide subject matter expertise and guidance to various departments and functional areas including Quality, MSAT, Technical Support, and Validation
* Work with Corporate Statistics group to ensure all statistical methods comply with regulations, guidance and standards published by FDA, ICH, EMA and other regulatory groups in project area
* Provide on-site statistical training as required
* Co-author, review and/or approve SOPs, protocols and reports containing significant statistical content with minimum supervision
* Perform process and data analysis for annual product reviews (APR) and periodic SPC reviews and support process investigations
* Maintain and demonstrate knowledge of state-of-the-art statistical practices and theories, and adopt them for successful completion of projects
* Provide technical leadership in tasks that include DOE, analysis of data, statistical process control (SPC), Quality by Design (QbD), simulation, design of sampling plans, and problem solving
* Develop and implement process monitoring tools
* Provide guidance to less experienced staff as needed
* BS degree & 7 + years of relevant experience OR Master's degree in statistics/biostatistics/mathematics & 4 + years of experience OR PhD in statistics/biostatistics or PhD in related disciplines & 2 + years of experience.
* Understanding of R&D, assay development, and manufacturing processes (including SPC and method/process validation)
* Expert knowledge and expertise in ANOVA, Regression, and statistical process control (SPC), Generalized Linear Models and Multivariate Methods such as PCA/ PLS.
* Experience programming in statistical software package (e.g., SAS, JMP)
* In-depth statistical knowledge in R&D, Manufacturing, and Quality, including MVA and MVSPC
* Experience with additional statistical and database management software (e.g., R, MATLAB, SIMCA, MS Access, Oracle, etc.)
* Experience in application development using SAS/R.