Bio Statistician/Non-clinical biostatistician

Location: Andover, Massachusetts
Posted On: 9/29/2017
Job Code: 8644-1
Job Description
Job Description:
Non-clinical biostatistician to be a part of a biostatistics group to provide expertise, data analyses and support to biotechnology derived drug manufacturing operations in close interaction with scientists, engineers, technicians and other statisticians from drug manufacturing and drug development organizations. Ability to communicate and write technical reports clearly so the analyses and conclusions can be understood both by statisticians and non-statisticians is a key to be successful in this position. A local resident from greater Boston area is preferred.

• Recommend sample size, test designs and acceptance criteria for validations, transfers and qualifications of analytical methods and critical reagents, and comparability studies
• Provide input to SOPs, validation and qualification protocols and reports
• Recommend QC assay control limits and evaluate assay performance
• Perform stability analysis of drug products and estimate stability trends (rate of change)
• Provide statistical input to standard curves, reference standards and replicate sample sizes of bioassays
• Recommend environmental monitoring limits and rules
• Support investigations of deviations, and unusual and OOS results
• Participate in setting drug specifications, process limits and product shelf life
• Provide technical input in support of regulatory submissions and queries
• Document statistical conclusions and results in presentations and reports
• Standardize statistical methodologies and processes across multiple sites
• Advanced degree in statistics or related discipline TECHNICAL SKILLS
• At least five years of biostatistics experience preferably in pharmaceutical industry under cGMP environment
• Mastery in design of experiments, statistical process control, hypothesis testing, statistical modeling (linear and non-linear regression, ANOVA), multivariate analysis (PCA, PLS) and simulation
• In-depth knowledge in statistical methodologies used in specification setting, pharmaceutical stability, analytical methods validation, equivalence test
• Familiarity with prediction, confidence and tolerance intervals, data transformations, process capability indices and acceptance sampling standards
• Proficiency in statistical software packages (e.g., JMP, R, MINITAB and SAS) and MS Office (Excel functions, VBA, Word and PowerPoint)
• Knowledge of cGMPs, FDA/EMA and other regulatory guidelines (e.g., ICH, USP, EP) as applied to drug manufacturing • Experience in authoring technical reports, documents or professional journal articles Position

Category:Non-IT  code:new
Job Requirements
SAS, MS Office, MS Excel, VBA, MS Word, Visual Basic

Not Ready to Apply?
Contact Details
Ajaykrishnan Ks