The Senior Statistical Programmer provides programming support with supervision to the biostatistics and clinical programming functions. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures. This role can be located in our Morrisville, NC or Carlsbad, CA offices OR home based.
Specific tasks would include:
- Creates/maintains analyses, tables/listings/figures
- Performs programming validation/QC
- Creates specifications for, and program derived datasets
- Provides ad-hoc reports as requested
- Assists in programming edit checks
- Works with Sponsor/statistician to write/review SAP, including mock tables and listings.
- May provide comments and suggestions on internal SOPs and training instructions.
- May train and provide guidance to other statistical programmers.
- May generate randomization schedules.
- Bachelor's degree or equivalent in mathematics, statistics, or related field of project and a minimum of 5 years related experience or equivalent combination of education and experience.
- Experience in CDISC (Adam and SDTM)
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Experience being the lead on a study
- Experience working on submissions is nice to have
- Proficiency in BASE SAS, SPSS or other statistical software.
- Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
- Nonverbal symbolism experience (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.
- Good proficiency in Microsoft Word, Excel, and PowerPoint, Access.
- Effective verbal and writing skills; English + local language, if relevant.