Senior Programmer, Programming

San Diego, CA

  • Samumed is seeking an experienced and talented programmer to join its Programming group as a Statistical Programmer - Sr. Project Lead.
  • 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

  • Managing and leading programming activities in a drug development program; contribute to the development of timelines and resource planning
  • Creating/reviewing specifications for CDISC SDTM modelled tabulation data sets (TD), CDISC ADaM modelled analysis data sets (AD) and final CSR tables, figures, and listings (TFL)
  • Developing and validating 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
  • Performing 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
  • Reviewing and providing 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)
  • Applying ICH guidelines and submission standards to ensure that programming deliverables follow regulatory requirements as well as industry and company standards
  • Oversee maintenance of internally developed data package submission standards guidelines compliant with FDA and CDISC guidance
  • Maintaining and developing macro tools to improve efficiency for common programming tasks
  • Leading, in conjunction with QA and IT, applicable system-level validations and ongoing change control 
  • Leading the development and continuous improvement of programming processes and keeping abreast of current data standards and data package submission requirements
  • Training personnel on the CDSIC SDTM and ADaM, and provide implementation guidance
  • Effectively communicating in a project team environment, within department, and among functional groups
  • Performing other programming duties as assigned

Requirements

  • Minimum of BS required in Mathematics, Statistics, Computer Science, Life Sciences, or other related field
  • BS with 5+ years or MS with 4+ years of programming experience, at least 3 years of which are with SAS in clinical research
  • In-depth knowledge of applicable clinical research regulatory requirements (i.e. GCP and ICH)
  • Expertise in CDISC SDTM implementation (3+ years), and CDISC ADaM implementation (1+ years) experience
  • 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. NO PHONE CALLS PLEASE.