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
Leads specialized Biostatistics development projects as requested by Management
May generate randomization schedules
Researches regulatory requirements and implements standards and processesfor Biostatistics output and the submission of clinical data to include CDISC
Performs senior level reviews, develops macros, time estimates and will carry out problem solving
Supports the departmental training process
Suggests and implements improvements and strategies for enhancing company operations
Evaluates programming software and provides input on selection
May perform other duties as assigned.
Performs all duties in accordance with SynteractHCR Standard Operating Procedures (SOPs), government regulation, Good Clinical Practice (GCP) and Good Documentation Practice (GDP).
Bachelor's degree or equivalent in mathematics, statistics, or related field of project and a minimum of 12 years related experience or equivalent combination of education and experience.
Advance 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
Good verbal and written communication (English and local languages)
Proficiency in MS-Office (such as Word, Excel, Powerpoint, Access) as required by the role