Principal Scientist, Biostatistician and Process Analytics

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World. 

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. 

Position Summary

The Biostatistician within Development provides advanced statistical support for multiple Development and Manufacturing Science and Technology (MSAT) projects, from process and analytical development, process characterization, registration applications, through post-approval lifecycle management to support internal and client projects.

Duties & Responsibilities

• Initiate, execute, and defend advanced statistical analyses relative to biopharmaceutical processes, as well as implement quantitative testing methodologies.
• Design, evaluate, and coordinate data acquisitions, visualizations, and data management efforts necessary to perform rigorous modeling, interpret results, and autonomously prepare study reports according to business needs.
• Expert in the use of statistics and data sciences, including but not limited to the application of generalized linear modeling, time-series multivariate statistics including Principal Components Analysis and Partial Least Squares, Quality Control test method validations and transfer validations, ANOVA/means comparisons, design of experiments, hypothesis and equivalence testing, protocol development, specification determination, and continuous process verification (CPV) and Statistical Process Control (SPC) methodologies.
• Works independently, while also collaborating and representing best practices to promote statistical support and data analysis with process development and MSAT scientists, analytical sciences, QC/QA, manufacturing, and with clients.
• Responsible for training others in statistical design and analysis, support process characterization document- and analysis-related activities.
• Provide statistical expertise to support submission activities and documents, as well as meetings with and responses to Health Authorities and other process lifecycle activities, as needed.
• Support Process Characterization (PC) documentation preparation and review, data entry verification in PC documents, resource scheduling and coordination, risk assessment, experimental designs, statistical data analysis, and data reduction and reporting.
• Will lead a team of Statisticians, data scientists, and scientists/engineers.

Education & Experience

• Degree in Statistics, Data Science, Life Sciences, Engineering, or Applied Statistics with relevant experience working in Manufacturing/Contract Manufacturing:
  • Minimum of a B.Sc/B.Eng with 6+ years, M.Sc./M.Eng degree with 4+ years, or Ph.D degree with no experience (0 years)
• Prior MSAT or operations experience and background in Biologics (upstream or downstream), Antibody Drug Conjugate, Drug Product, Small Molecule, Cell & Gene Therapy, or mRNA is preferred
• Process and testing validation design and analysis, as well as demonstrated knowledge of the biologics lifecycle process is preferred
• Software proficiency in SAS, R, python, JMP, MS Office applications, with demonstrated ability in SAS programming to support data analysis using linear mixed models, generalized linear mixed models, survival and categorical methods is required
• Preference will be given to candidates with advanced knowledge of design of experiments, principal components analysis and partial least square modeling of process data using software including JMP and SIMCA Knowledge of statistical theory and application of statistical methodologies in assay validation and process performance data analysis is required

Knowledge, Skills, Abilities

• Manage Manufacturing Science and Technology Biostatistics and Process Analytics logistics and coach personnel within team and across teams
• Actively participate and contribute to training of employees in proper use of statistical data analytics tools (e.g. SAS, JMP, SPSS, SIMCA, Excel, Minitab, SEEQ, etc.) and in basic through advanced statistical methods and analysis (e.g. Hypothesis testing through MVA)
• Use high level biomathematics knowledge to drive statistical aspects to ensure effective and efficient experimental study designs, manage study parameters, risk assessments, and identify the appropriate statistical tools to address project objectives and/or support of regulatory submissions
• Collaborate with functional groups including process development, MSAT, analytical sciences, QC/QA, manufacturing, and clients to implement statistical study designs in support of technical process and analytical method transfers, optimizations, development, process performance qualifications, analytical method qualifications and validations, as well as process and analytical validations in compliance with regulatory and ICH guidelines
• Support creation of and leverage process data analytics and advanced data science programs, manage the data and build applicable workflows, and lead meetings for continuous process verification programs
• Analyze study data using the appropriate methodologies, author documentation, and report results to internal partners and clients, as applicable
• Apply broad knowledge of statistics in the application of new analytical methodologies and method trending
• Lead management and delivery of verified process and analytical data from batch records, electronic data systems, and/or other source data for analysis, manufacturing summary reports, cGMP deviations/investigations, annual product quality reports (APQRs), process monitoring, continuous process verification (CPV), support process troubleshooting, and client requests
• Lead and support implementation and enhancement of digital systems and automated analysis/visualization tools (Spotfire, Pi, Tableau, Power BI, etc.) utilized for streamlining process data management and data monitoring
• Interact with regulatory agencies and answer regulatory questions regarding biostatistics and data trending
• Author sections and review final study reports and prepare statistical sections supporting client health authority submissions and responses
• Support preparation, authoring, and review of Process Characterization (PC) documentation including organizing documentation associated with PC, including data analysis, document archiving and scanning, and managing data entry and associated verification
• Communicate and defend statistical aspects of complex statistics validation and process performance statistics registrations, lifecycle management, publication, and for management to ensure appropriate interpretation of results, decision-making, to support client regulatory approvals, as applicable
• Research, justify, and apply innovative approached to analyze complex process and/or analytical data and solve problems
• Lead multidisciplinary and multi-site project teams including continuous process verification activities and study designs
• Explain statistical concepts to non-statisticians and provide adequate statistical justifications for actions, decisions, and statements, when required
• Author cGMP out of tolerance investigation reports

Physical Demands

• Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
• Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment

• Position is primarily office based with occasional work in a classified GMP manufacturing environment.
• Dynamic, fast-paced, interactive, and entrepreneurial environment
• Position is a team and project-based position that will require occasional shift work, weekends, and holidays.

Supervisory Responsibilities 

The position may supervise a direct staff of 2-4 scientists/engineers and/or contingent workers. This position will lead the safety culture of the group.

Travel

Up to 10% travel may be required

Target Bonus

16%

Work Location

East Syracuse, NY 

We are an Equal Employment Opportunity (“EEO”) Employer. 

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!