Overview

The senior CMC Biostatistician will be a statistical resource for developing and commercializing cell therapies in oncology. This will include direct support in the design and analysis of process and analytical CMC activities and manufacturing and quality control.

Essential Functions and Responsibilities

• Provide statistical design and analysis supporting Process Development (including process development, process characterization, validation, and tech transfer/comparability)

• Provide statistical design and analysis supporting Analytical Development (including analytical development, qualification, validation, and method transfer/reproducibility)
• Perform analyses to support stability studies and shelf life/expiration dating
• Provide statistical analysis support to MSAT and Manufacturing for continued process verification, optimization and comparability studies, and deviations and investigations
• Provide statistical analysis support to ASAT and QC for reference and control qualification, method performance trending, and deviations and investigations
• Engage cross-functionally to promote collaboration and application of QbD principles.

• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

Travel – 10%

Required Education, Skills, and Knowledge

• Master’s or Ph.D. in Biostatistics/Statistics (or other related quantitative field)
• 8 years of experience in a similar role with at least 5 years as a statistician supporting CMC activities.
• Knowledge of theoretical and applied statistics, including statistical modeling, control charts, nonparametric methods, multivariate methods, and experimental design
• Proficiency with statistical software tools (SAS, R, JMP, Minitab)
• Strong verbal, written, and presentation skills

Preferred Education, Skills, and Knowledge

• Experience with FDA regulations and other industry-related guidance is preferred.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position, standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position's responsibilities at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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