Biotech/Pharmaceutical

Sr. Statistical Programmer -Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: As a Sr. Statistical programmer, you will use your SAS programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such as aCRF, programming specifications, and Define packages (including reviewer’s guides) for Phase 1 to Phase 4 clinical trials. The analysis datasets will be based on source clinical data provided by our client companies; mostly in the form of SAS datasets, but occasionally also as excel/csv files.

In addition, you will conduct quality control and quality assurance activities on datasets and outputs and may participate in company initiatives to improve efficiency of data management, analysis, and reporting (IT, methodology, automation, quality).

As a Sr. Statistical programmer, you will work closely in teams with other statistical programmers, statisticians, and drug development consultants supporting a variety of client projects (therapeutic areas, data types).

Qualifications:

  • B.Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields.
  • Clinical trials related work experience (6 years for M.Sc., 8 years for B.Sc.) in SAS programming, analysis and reporting in the context of drug development projects.
  • Well experienced in Pinnacle21 validation process.
  • Extensive experience in implementing CDISC standards, as well as annotating CRFs, creating specifications for SDTM and ADaM datasets
  • Experienced in creating Define.xml and the corresponding Reviewers’ Guide for SDTM and ADaM datasets.
  • Good verbal and written communications skills in English.
  • Demonstrated knowledge of clinical drug development.
  • Proficiency in conducting advanced statistical analyses.
  • Accuracy and sense of urgency and quality, timely delivery.
  • Ability to work on multiple collaborative projects, team player mentality.
  • SAS certification is a plus.
  • Experience with the R software platform (in addition to SAS) is a plus.

Tagged as: Sr Statistical Programmer - Remote