Senior SAS Programmer

Ardelyx

Newark, CA

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Analysis Skills, Biostatistics, Biotech and Pharmaceutical, Clinical Data, Clinical Data Management, Clinical Monitoring, Clinical Practices/Protocols, Clinical Trial, Clinical Trial Management, Computer Programming, Computer Science, Contract Research Organization (CRO), Data Analysis, Data Management, Data Sets, Delivery Management, Detail Oriented, Disease, Documentation, Electronic Data Capture (EDC), Employee Benefits, FDA (Food and Drug Administration), Health Plan, Identify Issues, Incentive Programs, Industry Standards, Insurance, Interpersonal Skills, Multitasking, Organizational Skills, Prescription Drugs, Programming Methodologies, Project/Program Management, Publications, Regulatory Submissions, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Team Player, Time Management, Traceability, Validation Plan, Validation Testing, Writing Skills

LOCATION

Newark, CA

POSTED

30 days ago

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.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 activitiesComplete projects while adhering to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of workParticipate in study statistical programming development and documentation to include datasets, tables, listings and graphs to meet project timelinesConduct thorough program verification and validation, troubleshoots technical issues, and ensures accuracy and reproducibility of SDTM, ADaM datasets and TLFsEnsure high-quality statistical programming documentation, including dataset specifications, validation plans, and traceability documentsWork closely with the Lead Biostatistician to create analysis specifications and analysis outputs following the instructions provided in the Statistical Analysis PlanAssist in the preparation and distribution of reports to the project team membersParticipate in the development and review of SOPs, working instructions, and associated documents for SAS programmingPerform other duties as necessary as assigned by managementQualifications:Bachelor’s degree, master’s degree preferred, in Statistics, Biostatistics, Computer Science or related field with 5 - 8 years of SAS programming or equivalent experience3+ years of pharmaceutical clinical trial experience preferredStrong understanding of clinical trial data and extremely hands-on in data manipulation, analysis, and reportingAdvanced knowledge of SAS including data steps, PROC’s, SAS MACRO and SAS GRAPHExperience with EDC and some Clinical Data Management packagesHands-on experience implementing SDTM and ADaM data standardsPreferred experience managing contractors and/or external vendorsPreferred experience working on FDA submissionsStrong interpersonal skills, strong organizational skills with great attention to details and the ability to multitask, and excellent written communication skillsThe 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.

About the Company

Ardelyx

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