Senior SAS Programmer

United States·Newarksenior

OtherProgrammer

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Overview

Key Responsibilities

Serve as the Lead Programmer to be responsible for the timeline and quality of all statistical analysis deliverables Manage and oversee contractors and external vendors for SAS programming activities Complete projects while adhering to departmental…

Requirements Summary

Bachelor’s degree, master’s degree preferred, in Statistics, Biostatistics, Computer Science or related field with 5 - 8 years of SAS programming or equivalent experience 3+ years of pharmaceutical clinical trial experience preferred Strong…

Technical Tools

statistical-modeling

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

Position Summary:

The Senior SAS Programmer is responsible for applying advanced programming techniques to support the development and validation of statistical programs to be used for monitoring, analyzing, and reporting of Ardelyx’ clinical trial data for regulatory submissions and publications across multiple disease areas at Ardelyx. This position works closely with Biostatisticians, Data Managers, Clinical Trial Managers, and if necessary, Contract Research Organizations (CROs) and/or SAS programming consultants, to meet project deliverables and timelines for clinical data monitoring, analyzing, and reporting.

Responsibilities:

Serve as the Lead Programmer to be responsible for the timeline and quality of all statistical analysis deliverables
Manage and oversee contractors and external vendors for SAS programming activities
Complete projects while adhering to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
Participate in study statistical programming development and documentation to include datasets, tables, listings and graphs to meet project timelines
Conduct thorough program verification and validation, troubleshoots technical issues, and ensures accuracy and reproducibility of SDTM, ADaM datasets and TLFs
Ensure high-quality statistical programming documentation, including dataset specifications, validation plans, and traceability documents
Work closely with the Lead Biostatistician to create analysis specifications and analysis outputs following the instructions provided in the Statistical Analysis Plan
Assist in the preparation and distribution of reports to the project team members
Participate in the development and review of SOPs, working instructions, and associated documents for SAS programming
Perform other duties as necessary as assigned by management

Qualifications:

Bachelor’s degree, master’s degree preferred, in Statistics, Biostatistics, Computer Science or related field with 5 - 8 years of SAS programming or equivalent experience
3+ years of pharmaceutical clinical trial experience preferred
Strong understanding of clinical trial data and extremely hands-on in data manipulation, analysis, and reporting
Advanced knowledge of SAS including data steps, PROC’s, SAS MACRO and SAS GRAPH
Experience with EDC and some Clinical Data Management packages
Hands-on experience implementing SDTM and ADaM data standards
Preferred experience managing contractors and/or external vendors
Preferred experience working on FDA submissions
Strong interpersonal skills, strong organizational skills with great attention to details and the ability to multitask, and excellent written communication skills

The anticipated annualized base pay range for this full-time position is $140,000 - $172,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.