Manager, Statistical Programming

Kite Pharma

1d

About The Position

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. Job Description We are in search of a Manager, Statistical Programming to join our team! Statistical Programming– Analysis Programming: 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.

Requirements

• BS degree in Biostatistics/Computer Science or equivalent and 7 years’ experience in pharma/biotech
• OR - MS degree in Biostatistics/Computer Science or equivalent and 4 years’ experience in pharma/biotech
• OR - PhD degree in Biostatistics/Computer Sciences or equivalent
• 2 years of experience in pharma/biotech

Nice To Haves

• Degree in Biostatistics/Computer Science or equivalent
• 6+ years of pharmaceutical/CRO experience
• Prior experience in oncology, hematology, and cell therapy is strongly preferred.
• Knowledge of long term follow up trial knowledge 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

Responsibilities

• 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
• Actively share experience and discuss possible process enhancements at programming meetings
• Recommends potential trainings
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
• Responsible for all programming activities within a therapeutic project or equivalent
• Implements strategic initiatives
• Able to lead and manage multiple concurrent projects
• Excellent verbal and written communication skills and interpersonal skills
• Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions
• 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
• Interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis
• Participates in SMT (Study Management Team) meeting as a representative of Programming group

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager