Senior Manager, SAS Programming

Clinical Fremont, California

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Description

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 Manager of SAS Programming is responsible for implementing and managing statistical programming activities; developing, validating, and maintaining SAS programs to support statistical programming used for monitoring, analyzing, and reporting Ardelyx’s study data for regulatory submissions and publications across multiple disease areas. This position develops and maintains all standard operating procedures (SOPs) related to statistical programming and CDISC standard implementation. This position works closely with Biostatisticians, Data Managers, Clinical Trial Managers, and Contract Research Organizations (CROs) and/or SAS programming consultants to meet project deliverables and timelines for data monitoring, analysis, and reporting.
 
Responsibilities:
  • Lead and oversee statistical programming activities for clinical trials, ensuring compliance with regulatory requirements and industry best practices
  • Manage and coordinate work with external vendors, contractors, and CROs for SAS programming activities
  • Act as the Lead Programmer, taking ownership of project timelines, quality control, and the delivery of statistical programming outputs
  • Develop, implement, and maintain programming standards, templates, and conventions to streamline statistical programming processes
  • Develop and review SOPs, working instructions, and associated documents for SAS programming
  • Oversee adherence to CDISC standards, including SDTM and ADaM data structures, ensuring consistency and compliance across projects
  • Apply advanced-level programming techniques to the planning, implementation, and maintenance of SAS programs for data monitoring, reporting, and analysis of clinical trials
  • Ensure high-quality statistical programming documentation, including dataset specifications, validation plans, and traceability documents
  • Conduct thorough program verification, troubleshoots technical issues, and ensures accuracy and reproducibility of SAS outputs
  • Collaborate with the Lead Biostatistician to create analysis file specifications and analysis outputs following the instructions provided in the Statistical Analysis Plan
  • Provide mentorship, guidance, and training to junior statistical programmers as needed
Qualifications:
  • Bachelor’s in Statistics, Biostatistics, Computer Science, or related field with 10 years of SAS programming and 4+ years of pharmaceutical clinical trial experience serving as a Lead Programmer
  • Master’s degree in Statistics, Biostatistics, or Computer Science is preferred
  • Advanced proficiency in SAS programming, including macro development, data manipulation, and statistical analysis procedures
  • Knowledge of registration filing requirements for statistical programming, as well as adherence to good programming procedures. Experience in FDA filings is preferred
  • Knowledge of basic statistics and ability to communicate with statisticians and sometimes non-statisticians to verify and interpret tables, listings, and figures
  • Hands-on experience with implementing SDTM and ADaM data standards
  • Preferred experience managing contractors and/or external vendors
  • Must be able to work both independently and collaboratively in a team environment
  • Strong organizational and problem-solving skills with great attention to detail and the ability to multitask
  • Strong verbal and written communication skills
The anticipated annualized base pay range for this full-time position is $176,000 - $216,000. 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.

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