Manager, Statistical Programming
BiometricsRegularDescription de l'emploi
Kite Pharma, a Gilead company, is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced hematological and solid malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.
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.
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
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
Basic Qualifications:
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
Preferred Qualifications:
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
People Leader Accountabilities:
•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.