Senior Manager SAS Programming
Senior Manager SAS Programming
Posted on :
23-04-2025
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1 Vacancy
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Job Description
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative firstinclass 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 Ardelyxs 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 advancedlevel programming techniques to the planning implementation and maintenance of SAS programs for data monitoring reporting and analysis of clinical trials
- Ensure highquality 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:
- Bachelors 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 or equivalent experience
- Masters 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 nonstatisticians to verify and interpret tables listings and figures
- Handson 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 problemsolving 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 fulltime position is $176000 $216000. 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.
Required Experience:
Senior Manager
Employment Type
Full-Time
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