Statistical Programmer - Project Lead, Programming

San Diego, CA

  • Samumed is seeking an experienced and talented programmer to join its Programming group as a Statistical Programmer. 
  • This position will lead programming support for multiple studies in multiple stages of clinical development.
  • This position will interact with Biostatistics, Clinical Data Management, Medical Writing, Clinical Operations, and Regulatory to design, write, and validate SAS® programs in accordance with company, industry, and regulatory requirements.

Specific Responsibilities

  • Manage and lead programming activities in a drug development program; contribute to the development of timelines and resource planning
  • Create/review specifications for CDISC SDTM modelled tabulation data sets (TD), CDISC ADaM modelled analysis data sets (AD) and tables, figures, and listings (TFL)
  • Develop and validate SAS® programs to produce high quality deliverables for in-house projects in compliance with company and regulatory requirements. The deliverables include TD, AD, define.xml, and TFL
  • Perform conformance checking of CDISC modelled TD and AD using Pinnacle 21’s OpenCDISC Community tool and applicable regulatory agency data standards requirements to ensure data sets follow submission standards
  • Review and provide input on documents produced by other functional groups, including: statistical analysis plans (SAP), data presentation plans (DPP), data management plans (DMP), data transfer agreements (DTA), Medidata Rave study design specifications (SDS), and case report forms (CRF)
  • Apply ICH guidelines and submission standards to ensure that programming deliverables follow regulatory requirements as well as industry and company standards
  • Develop global macro tools to improve efficiency for common programming tasks
  • Lead the development and continuous improvement of programming processes and keep abreast of current data standards and data package submission requirements
  • Train personnel on the CDSIC SDTM and provide implementation guidance
  • Effectively communicate in a project team environment, within department, and among functional groups
  • Perform other programming duties as assigned


  • Minimum of BS required in Mathematics, Statistics, Life Sciences or other related field
  • BS with 6+ years or MS with 4+ years of SAS programming experience in clinical research
  • In-depth knowledge of applicable clinical research regulatory requirements (i.e. GCP and ICH)
  • Expertise in CDISC SDTM implementation (4+ years); CDISC ADaM implementation experience a plus
  • Excellent written and verbal communication skills
  • Excellent organizational skills as demonstrated by effectively handling multiple tasks and projects

Please submit your resume or additional inquiries to Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.