Provide consulting of statistics activities related to clinical trials
Fulfill the responsibilities of study statistician as required
Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications
Act as study statistician
interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel
Develop, review, and finalize the statistical analysis plan
Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
Develop randomization schedule, specifications, and guidelines
Where applicable, provide input in finalization of study specific data quality control plan
Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
Analyze the data and contribute to trial progression related decisions
Collaborate with team members for regulatory reviews, representations, and supporting data analyses

Master in Statistics, Biostatistics, or equivalent work experience preferred
Excellent knowledge of English
SAS® certification is preferred
5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
Strong experience with clinical study design development, analysis, and sample size determination
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
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
Ability and experience of delegating tasks and leading projects

Principal Biostatistician

Key skills