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Senior Statistical Programmer

3 weeks, 3 days ago
United States
Full-time
Senior
Software Engineer
Software Development
Apply Now
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984
View All Jobs 14

Description

  • Lead and participate in the development and validation of high-quality CDISC datasets.
  • Author SDTM specifications from study protocols, CRFs, vendor data transfer agreements, data sources, and CDISC guidance.
  • Create agency-accepted eSubmission deliverables, including define.xml and other submission components.
  • Run data conformance checks using Pinnacle 21 and resolve issues in dataset development and submissions.
  • Convert specifications into SAS code, analyze code errors, and revise programs as needed.
  • Write, maintain, and review documentation for code, programs, specifications, and user/technical materials.
  • Review statistical analysis plans, protocols, CRFs, validation plans, and related study documents, and provide feedback to Biostatistics and project teams.
  • Serve as a CDISC subject matter expert and provide guidance on database design, CDASH data collection, and study start-up through closeout.
  • Mentor and train junior programmers and peers in areas of expertise.
  • Lead programming activities on assigned projects while maintaining scope, budget, and communication with senior management.

Requirements

  • BA/BS in computer science, statistics, or a related field.
  • At least 6 years of statistical programming experience in SAS within the CRO or pharmaceutical industry.
  • Extensive end-to-end SDTM experience, including raw data transformation, specification, programming, and conformance to CDISC standards.
  • Experience with ADaM specification, programming, and conformance is a plus.
  • Strong SAS/Base knowledge with emphasis on data step programming.
  • Ability to modify pre-existing SAS code and write SAS code from specifications.
  • Knowledge of clinical trial regulatory requirements, including GCP and ICH guidelines.
  • Experience with data/submission conformance tools such as Pinnacle 21, define.xml creation, SDSP, and study data reviewer’s guides.
  • Strong written, verbal, and presentation communication skills.
  • Demonstrated attention to quality, critical thinking, adaptability, and collaborative work style.

Benefits

  • Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life insurance, disability insurance, and 401(k).
  • Paid time off for all employees.
  • Paid holidays.
  • Parental leave.
  • Bereavement leave.
  • Flexible work-life balance support.
  • Starting salary range of $110,000 to $135,000 per year.

Interested in this position?

Apply directly on the company website

Apply Now

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