Senior Manager, Statistical Programming

Kite Pharma

1d•$153,935 - $199,210

About The Position

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. 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

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.

Nice To Haves

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.

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.
Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project. Inform 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.
Inform functional management programming resources required for the project.
Recommends and provides trainings.