Veterans Preferred - Senior Quality Engineer II - Biostatistician:
Kite Pharma

Description

Military Veterans are Encouraged to Apply.

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are currently seeking a Senior Quality Engineer II - Biostatistician to join our Quality team.

The Senior Quality Engineer II - Biostatistician will act as an in-house specialist in applying statistical methodology and innovation within Kite Pharma's Quality organization and will develop innovative, efficient statistical methods for ready-to-use application in Kite's studies, projects, and regulatory submissions.

Please note that this position can be based out of one of 3 different Kite locations: Santa Monica, CA; Oceanside, CA; and Frederick, MD .

Responsibilities of the Senior Quality Engineer II include, but are not limited to:

• Identify, evaluate, and apply innovative statistical methods for study design and analysis of data related to stability, batch analysis, investigations, analytical method performance, method transfer, and method validation
• Analyze data to support development of final product and in-process material specifications
• Support regulatory filings, responses to questions, and regulatory inspections
• Present analyses and proposed strategies in cross-functional forums
• Author technical reports, position papers, and regulatory submissions
• Assist with the coaching, mentoring, and training of non-statisticians, as required, on the appropriate use of statistical methodologies for their business processes
• Promote broad usage of innovative, complex statistical methods and mentor other statisticians and functions in applying them to their projects; provide training, consultancy, and perform prototype usage of complex or innovative methods
• Collaborate with a wider data analytics community within and outside the Quality function to identify best practices and align on statistical tools and methodologies
• Establish standard practices and influence the practices applied in the cell therapy industry through external meetings and conferences

Basic Qualifications:

• PhD OR
• Master's Degree and 6+ years' experience in biotech / biopharma, technical operations OR
• Bachelor's Degree and 8+ years' experience in biotech / biopharma, technical operations OR
• High School Degree and 12+ years' experience in biotech / biopharma, technical operations

Preferred Qualifications:

• 6+ years' experience in a technical operations role in the biotech / biopharma industry
• Degree in Mathematics, Statistics, or Biostatistics preferred
• CMC experience strongly preferred
• Deep technical expertise in SAS and/or R with a proven track record of extending and implementing statistical concepts into ready-to use software
• Excellent scientific background and capability of understanding innovative, complex statistical methodology and concepts
• Ability to understand basic concepts within science and technology for manufacturing & QC testing and creatively design studies and analytical methodologies to work with the challenges of cell therapy; willingness to apply pragmatic and flexible approaches
• Ability to engage, challenge, and extend complex methodological topics and interact with other statisticians on statistical-methodological issues for complex projects
• Strong communication skills to effectively communicate the findings of analyses with others in the organization; this includes both verbal and written communication, as well as the ability to present data in easy-to-understand, visual ways
• Ability to think critically about the data being analyzed through the lens of key stakeholders and executives; skilled in identifying trends and data points that can have a major impact on the organization
• 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

#LI-ML1

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to on Twitter at .

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.