Minimum 5 + years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role (For Manager, candidate should have 10+ years of experience)
Strong experience with clinical study design development, analysis, and sample size determination.
Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule.
Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA.
Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses,
Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes.
Knowledge of CDISC related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures.