Manager, Statistical Programming - Translational
Job description
Job Description
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
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 Registry and Data Statistical Science teams to meet project deliverables and timelines for statistical data analysis and reporting. Serves as project leader.
- Collaborate with CDM (Clinical Data Management) with the review of PK/PD, Biomarker data transfers and perform data/edit checks
- Utilizes internal databases such as clinical trial data, electronic medical records, health claims, the patient reported outcomes, registries and publicly available data to execute inhouse analytical projects.
- Generates the production of programming deliverables (e.g., tables, figures, listings) for clinical registry study and data science reports, as well as integrated summaries. Successfully interacts within Biometrics and Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
- Conducts analyses and develops programming specifications for descriptive and complex statistics in studies using registry or real-world data.
- Performs programming using SAS or R, testing, mapping, and documentation of registry and real-world evident projects to meet business needs.
- Responsible for all programming activities within a project or equivalent and implements strategic initiatives.
- Able to lead and manage multiple concurrent projects.
- Excellent verbal and written communication skills and interpersonal skills.
- Ability to resolve study related issues and conflicts within project.
- Can create buy-in and support and has the ability to negotiate timelines.
- Actively shares experience and discusses possible process enhancements at programming meetings.
- Recommends potential trainings.
Basic Qualifications:
- BS degree in Biostatistics/Computer Science or equivalent and 6 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 and experience in pharma/biotech
Preferred Qualifications:
- Degree in Biostatistics/Computer Science or equivalent
- 6+ years of pharmaceutical/CRO experience
- Experience with PK/PD, Biomarker, or strong programming experience handling Oncology data
- Knowledge of registry and real-world data; experience in observational research, programming execution and communication are strongly preferred.
- Extensive statistical programming experience using SAS and R; demonstrated proficiency in statistical analysis programs are strongly preferred.
- Prior experience in oncology, hematology, cell therapy is preferred.
- In-depth understanding of clinical programming and/or statistical programming processes and standards.
- Advanced knowledge in CDISC standards (e.g. ADaM).
- Proven experience in leading programming activities.
- Excellent interpersonal, communication, problem solving, and analytical skills.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For jobs in France:
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