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

Requirements

  • 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 apply@samumed.com. 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.