Statistical Programmer II

Kite Pharma

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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

Master’s and 2 years of relevant experience OR Bachelor’s and 4 years of relevant experience

Nice To Haves

Degree in Biostatistics/Computer Science or equivalent.
5+ years of pharmaceutical/CRO experience.
Prior experience in oncology, hematology, cell therapy 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 and R software including development and use of SAS Macros, R Packages.
Experience with development of CDISC standardized ADaM datasets and specifications .
Advanced knowledge in SDTM domains.
Proven experience in leading programming activities.
Excellent interpersonal, communication, problem solving, and analytical skills.
Willing to handle multiple projects and ad-hoc tasks.

Responsibilities

Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
Assesses the quality and consistency of analysis data and performs cross-study analyses.
Uses internal macros or writes SAS® macros to automate study deliverables.
Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies.
Has sufficient understanding to follow an analysis plan and provide programming support for study deliverables
Assist in the review of GSI Policies, SOPs and other controlled documents
Provide input to and participate in Programming and Clinical Data Science meetings.
Contribute to the continuous improvement of Programming Environment.
Excellent verbal and written communication skills and interpersonal skills are required.
Demonstrates SAS programming proficiency.
Generates the production of statistical analysis datasets and outputs (e.g., tables, figures, and listings) for study reports and integrated summaries.
Has knowledge of clinical trial study design and electronic data submission requirements.
Assist with study and systems audits, and respond to audit questions and findings
Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies and helps define the data set.