Sr Statistician

Job Description

Job Responsibilities:

Kite is seeking a highly motivated individual to work on innovative CAR-T cell therapy for cancer

treatment. As a Senior Statistician II in the Statistical Sciences & Analytics (SS&A) group of Network

Manufacturing Sciences and Technology (NMSAT), you will identify, develop and implement statistical methods to support new product introductions and GMP manufacturing for Kite’s engineered autologous T cell therapy products. The Sr. Statistician will also help establish a statistics center

of excellence to create statistical standards and harmonize statistical methods across Kite using industry guidance and best practices.

Key Responsibilities include:• Identify, evaluate and apply appropriate statistical methods for study design and analysis of data related

to process validation, tech transfers, process monitoring, investigations, analytical method performance,

and product performance

• Support the development of final product, in-process and raw material specifications

• Consult and defend statistical approaches used in regulatory filings, response to questions, and

regulatory inspections

• Present analyses and proposed statistical / analytical strategies in a variety of cross-functional forums

• Author internal technical reports, position papers, and contribute to content for regulatory submissions

• Assist with coaching, mentoring, and training of data analysts and non-statisticians on the appropriate

use of statistical methodologies and statistical software for their business processes

• Contribute to department policies and procedures in support of establishing of a statistics center

of excellence to harmonize and align on statistical tools and methodologies across Kite using industry

guidance and best practices

• Develop and promote the use of advanced statistical methods, e.g., Bayesian methods or

predictive analytics, that contribute to a competitive advantage for Kite within the broader market

• Affect statistical practices in the cell therapy industry through external meetings and conferences

Basic Qualifications:

• PhD 0+ years’ experience OR

• Master’s Degree and 6+ years’ experience in biotech / biopharma, high-tech industries OR

• Bachelor’s Degree and 8+ years’ experience in biotech / biopharma, high-tech industries OR

• High School Degree and 12+ years’ experience in biotech / biopharma, high-tech industries

Preferred Qualifications:

• Advanced degree (MS or PhD) in applied or industrial statistics highly preferred, with proficiency in Design of Experiments, Statistical Quality Control, advanced modeling and simulation, Bayesian methods,

and multivariate methods. Knowledge of Machine Learning, NLP or AI, is a plus.

• 2 + years’ experience in a technical role in the biotech / biopharma industry or other high-tech industry

• Chemistry, Manufacturing and Controls (CMC) experience in gene or cell therapy is preferred

• Proficiency in SAS, SAS Viya, JMP and R with a demonstrated experience of implementing statistical concepts into ready-to use software

• Practical experience with cGMP manufacturing and regulatory regulations for CAR-T cell products or pharmaceuticals

• Excellent scientific background and ability to drive data driven decision making within

technical organizations and to engage, challenge and extend complex methodological topics,

and interact with other statisticians on statistical-methodological issues for complex projects

• Excellent communication skills to effectively communicate the findings of analyses with others in their organization; this includes both verbal and written communication, as well as the ability to present data in easy-to-understand, visual ways

• Excellent interpersonal skills and the ability to interact effectively with internal and external stakeholders across different functions

• Fluency in written and spoken English with excellent writing, presentation, and teaching skills

• Ability to function efficiently and independently in a changing environment

• Adaptable and comfortable in a collaborative and inclusive company environment

• Ability to lead a cross-functional and diverse team while fostering inclusion

• Creative and thoughtful problem-solving skills