Senior Manager, Statistical Programming
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Job Description
Senior Manager leading statistical programming for Kite’s cancer immunotherapy development. Managing programmers, clinical-trial analyses, regulatory submissions, and statistical outputs.
Responsibilities:
- Work collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting
- Serve as project leader
- Generate or oversee programming deliverables, including tables and listings, for study reports and integrated summaries
- Interact within Biometrics, Clinical Data Science, Clinical Development, and Regulatory Affairs groups
- Anticipate resource needs and work with management and HR on long-term resource allocation within a therapeutic project
- Inform functional management of programming resources required for projects
- Manage a small team of programmers, including FTEs and contractors
- Design and/or code analysis files
- Ensure programming and documentation follow departmental procedures
- Be responsible for programming activities within a therapeutic project or equivalent
- Provide primary and secondary programming support as needed
- Implement strategic initiatives
- Define and produce user-defined statistical reports and ad hoc requests
- Resolve study-related issues and conflicts within a therapeutic project
- Negotiate timelines and create buy-in and support
- Directly supervise personnel and perform task or performance management as required
- Participate in cross-functional meetings as a Programming representative
- Represent the Company on contracts when applicable
- Recommend and provide trainings
- Create inclusion, develop talent, and empower teams as a people leader
Requirements:
- 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent
- 6 years of experience and an MS degree in Biostatistics/Computer Science or equivalent
- 0 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent
- Advanced degree in Biostatistics/Computer Science or equivalent preferred
- 8+ years of pharmaceutical/CRO experience preferred
- Prior experience in oncology, hematology, or cell therapy strongly preferred
- Hands-on experience in pivotal studies and/or regulatory submissions, including NDA, BLA, and MAA
- In-depth understanding of clinical programming and/or statistical programming processes and standards
- In-depth understanding of regulatory requirements relevant to statistical programming, including GCP and ICH
- Extensive experience with statistical programming using SAS, including development and use of SAS Macros
- Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM
- Proven experience leading programming activities
- Excellent verbal and written communication, interpersonal, problem-solving, and analytical skills
- Thorough understanding of clinical trial design and reporting processes, regulatory reporting requirements, and electronic data submissions
- Ability to interact with others to define and produce user-defined statistical reports
- Ability to resolve study-related issues and conflicts
- Ability to negotiate timelines and create buy-in and support
- Ability to directly supervise personnel; performance or task management may be required
Benefits:
- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives eligibility may vary based on role
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Benefits package
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