Senior SAS Programmer

Ardelyx • Newark, CA

3d • $140,000 - $172,000

About The Position

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.
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.

Requirements

• 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
• Strong interpersonal skills, strong organizational skills with great attention to details and the ability to multitask, and excellent written communication skills

Nice To Haves

• Preferred experience managing contractors and/or external vendors
• Preferred experience working on FDA submissions

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level