Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies.
With our mission of Bringing Clinical Trials to Life, we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations.
Our mission is to support the innovation and development of better therapies in healthcare. Position Overview 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.
Specific tasks would include :
Creates / maintains analyses, tables / listings / figures
Performs programming validation / QC
Creates specifications for, and program derived data sets
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.
Proficiency in Microsoft Word, Excel, and PowerPoint, Access.
Effective verbal and writing skills; English + local language, if relevant.