Senior Scientist, Biostatistician Mst At Lotte Biologics

Overview:

 

LOTTE BIOLOGICS located in East Syracuse, NY is seeking Biostatistician to join our team who entered the biologics Contract Development Manufacturing Organization (CDMO) business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, on January 1, 2023! 

The Biostatistician within Manufacturing Science and Technology (MSAT) provides advanced statistical support for multiple MSAT projects, from process and analytical development, registration applications, through post-approval lifecycle management. The Biostatistician will initiate, execute, and defend advanced statistical analyses relative to biopharmaceutical processes, as well as implement quantitative testing methodologies. The Biostatistician is expected to design, evaluate, and coordinate data acquisitions and data management efforts necessary to perform rigorous modeling, interpret results, and autonomously prepare study reports according to business needs. The Biostatistician is expected to be a proficient 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 Statistical Process Control (SPC) methodologies. The Biostatistician is expected to work independently and also to collaborate and represent best practices to promote statistical support with process development and MSAT scientists, analytical sciences, QC/QA, manufacturing, and with customers.

The Biostatistician will also be responsible for training others in statistical design and analysis. The candidate is expected to provide statistical expertise to support submission activities and documents, as well as meetings with and responses to Health Authorities and other drug development activities, as needed. The Biostatistician will serve as an individual contributor but may transition to lead a team of Statisticians.

 

Responsibilities:

• Actively participates and contributes 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, 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 customers 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 for continuous process verification programs, as applicable
• Provide statistical analysis for cGMP investigations of process and analytical data
• Analyze study data using the appropriate methodologies, author documentation, and report results to internal partners and customers, as applicable
• Apply broad knowledge of statistics and influence industry and regulatory agencies in the application of new analytical methodologies
• Compile statistics reports suitable for internal compliance, customer deliverables, and/or regulatory submissions
• Interact directly with regulatory agencies and answer regulatory questions regarding biostatistics matters
• 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, and acceptance for regulatory approvals
• Research, justify, and apply innovative approached to analyze complex process and/or analytical data and solve problems, as applicable
• Lead multidisciplinary and multi-site project teams
• Explain statistical concepts to non-statisticians and provide adequate statistical justifications for actions, decision, and statements, when required
• Lead planning and execution of innovative statistical analyses and eCTD preparation for regulatory submission and post-marketing activities including publications
• Author key sections and review final study report and prepare statistical sections of health authority submissions and responses with minimum support from management

Remote Position:falseBonus:10%Qualifications:

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), 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

 

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.

 

Travel:

This position requires up to 10% of domestic and/or international travel.

 

Work Location:

East Syracuse, NY

Company Website:

http://www.lottebiologics.com/

Company Profile:

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

 

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

 

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.