What are the responsibilities and job description for the Sr. Statistician position at Kite Pharma?
About Kite
We are dedicated to one goal: curing cancer. Every moment is focused on developing treatments that bring us closer to this goal. We have made significant scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm.
Job Description
Kite is seeking a highly motivated Senior Statistician II to work on innovative CAR-T cell therapy for cancer treatment. As a member of 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.
Key Responsibilities
- 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 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.
Requirements
- 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.
- 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.
- 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.
- 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.
