[Hiring] Senior Manager, Statistical Programming @Kite Pharma

Role Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.

Responsibilities (include but are not limited to):

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting. Serves as project leader.
• Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
• Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project.
• Informs functional management programming resources required for the project.
• Manages a small team of programmers including FTE and contractors.
• Designs and/or codes analysis files.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Is responsible for all programming activities within a therapeutic project or equivalent.
• Provides primary and secondary programming support as needed.
• Implements strategic initiatives.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions.
• Must be able to interact with others to define and produce user-defined statistical reports (e.g., ad hoc requests).
• Has the ability to resolve study related issues and conflicts within a therapeutic project.
• Can create buy-in and support and has the ability to negotiate timelines.
• Has the ability to directly supervise personnel.
• Performance or task management may be required.
• May serve as project leader.
• Participates in cross-functional meetings as a representative of Programming group.
• Interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Viewed as a key resource by more senior individuals on technical initiatives and may represent the Company on contracts.
• Recommends and provides trainings.

Qualifications

• 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
• 6 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
• 0 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

Requirements

• Advanced degree in Biostatistics/Computer Science or equivalent.
• 8+ years of pharmaceutical/CRO experience.
• Prior experience in oncology, hematology, cell therapy strongly preferred.
• Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.).
• In-depth understanding of clinical programming and/or statistical programming processes and standards.
• In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven experience in leading programming activities.
• Excellent interpersonal, communication, problem solving, and analytical skills.

Benefits

• The salary range for this position is: $153,935.00 - $199,210.00.
• Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.