Senior Statistical Programmer - Novato, CA | Biospace
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Senior Statistical Programmer

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Programmer, Statistics,

Job Description


Why Join Us?

Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  

Come join our team during this exciting time of growth and opportunities!

We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.  This position can be located in Novato or Brisbane.

Position Summary

Ultragenyx is looking for an experienced SAS programmer who is a self-starter with advanced technical skills and excellent communications skills. Reporting to the AD of the SAS programming group, the candidate will be responsible for the development and maintenance of statistical programming functions to support various projects. The candidate oversees the programming activities related to certain clinical programs.  The candidate will help with the development of the programming strategy, works in the development of the SAS programming Infrastructure, and coordinates the effort across therapeutic areas to identify, develop and implement departmental standards, applications, and processes. The candidate provides timely support to the project teams on  statistical programming matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level.

Responsibilities, including but not limited to:
•   Responsible for the development, review, validation, and execution of SAS programs to generate Tables, Figures, and Listing
•   Create and review annotated CRF to SDTM datasets
•   Responsible for the translation of the SAP into programming specifications for analysis data and model (ADaM) datasets
•   Review key study-related documents produced by other functions, such as case report forms
•   Responsible for reviewing the DMP, SAP and the TFL specifications, and provide feedback to the statisticians
•   Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets to be included in reports for submission to regulatory agencies, publications, and other communications
•   Experience in developing SAS macros to standardize the workflow and internal processes
•   Help with SAS Programming Infrastructure including the design, creation and validation of global SAS macros and utilities that streamline operations to increase programming efficiency
•   Support the development of statistical programming processes to ensure the best quality of the statistical outputs.
•   Manage  the programming activities on multiple projects/studies across various therapeutic areas, both internally and externally by CROs.
•   Provide support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives
•   Function as a positive role model for setting high expectations for quality, creativity and project ownership.
•   Works collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
•   Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers).
•   Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
•   Involved with the strategy for process improvement.
•   Identify new tools to increase efficiency and quality.

Requirements


•   Master’s Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
•   Minimum of 5-10 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
•   Advanced SAS programming skills and experience in other statistical software
•   Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
•   Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programing projects.
•   Excellent organizational skills and ability to prioritize tasks.

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.