Head of Biostatistics
Compensation: $104,595.00 - $171,740.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
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For Current Kite Pharma Employees and Contractors:
The Head of Biostatistics
will serve as the leader in Biostatistics for all programs across Clinical Development and Research at Kite. Through this role, this individual will be responsible for providing strategic input as it relates to program and portfolio decisions. This individual will serve as a strategic partner with other functional leaders from Clinical Research, Pharmacovigilance, Regulatory Affairs, Research, and others in support of the project teams and organizations. This individual will provide managerial direction to achieve effective, timely, and innovative solutions to development programs and research projects. This individual will maintain relationships with outside organizations and experts. This person has responsibility for statistical guidance to other functions in Clinical Development and Research, and will play a key role to ensure data quality and integrity meets the rigor and standards required for global product registration. This position will oversee the Biostatistics function and ensure systems, capabilities, and resources are in place that optimizes the design, collection, analysis, and interpretation of clinical and nonclinical data for each program.Key Responsibilities:
- Direct statistical support to the programs across Clinical Development and Research, including global filings and commercialization
- Develop strategies to enable the timely execution of the development programs that will meet global regulatory standards
- Ensure sufficient and effective strategic inputs and statistical expertise to support Clinical Development and Research
- Ensure allocation of resources to meet aggressive timelines associated with the advancement of clinical programs and regulatory submissions
- Promote rigorous quality standards and provide statistical strategies and solutions to the program teams to ensure overall data integrity and quality
- Identify, develop, and implement departmental standards, applications, processes, and trainings across biostatistics efforts in all programs
- Support generation of real-world evidence and other types of data for regulatory and market access purposes
- Accountable for overall management of the biostatistics function at Kite, such as planning of the budget, building and developing a world-class team (currently approximately 30 FTEs and contingent workers), and identifying technology needs or other gaps
- PhD in biostatistics, statistics, mathematics, or related field
- Minimum of 10 years of relevant work experience, with a proven track record of designing and implementing solutions to complex issues
- Thorough familiarity with statistics in various settings - from adaptive Phase 1 designs to Phase 2/3 trials
- Solid working knowledge of market access standards in multiple jurisdictions/countries beyond the US
- Understanding of bioinformatics, CMC statistics, and correlations, including surrogacy analyses
- Intellectual thought leadership, with strategic and critical thinking
- Strong leadership and management skills, and ability to effectively lead and collaborate with various business functions
- High attention to detail, including proven ability to manage multiple competing priorities
- Demonstrated ability to develop and implement business strategies across multiple disciplines and proven success leading change/transformational efforts
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 www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .For jobs in the United States:
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 ...@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors:
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Associated topics: aseptic, bioengineering, biology, biostatistics, life science, metabolism, pathophysiology, protein, stem cell, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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