Job Title

Summary: The Principal Biostatistician takes the lead on statistical projects, working collaboratively with the STATs and CDM groups to ensure high quality statistical deliverables. We are looking for someone who has: - MSc. or PhD. in Biostatistics, Statistics or related field - Minimum 7 years experience as a Biostatistician in Pharma/Biotech Industry. CRO experience as asset - Therapeutic experience in Oncology, CNS and orphan drug indications - Proven experience leading Statistical Projects - In-depth knowledge and application of CDISC, SDTM and ADaM submissions - In-depth knowledge of FDA and ICH regulations and guidelines - Excellent written and verbal communication skills - Cooperative and team-oriented - Self-motivated and detailed-oriented - Ability to work to tight deadlines while maintaining high standards What you will be doing (Project-by-project basis): - Act as the Lead Biostatistician / Project Manager - Interface with Sponsor: collect requirements, determine timelines/resource allocation of statistical deliverables - Author Statistical Analysis Plans - Author/Contribute to Randomization, Sample Size Calculation and Statistical Methods section of protocols - Responsible for development of ADaM package: author, review/QC ADaM specifications, assess impact of protocol amendments and DB design changes on SAP, SDTM and ADaM package, and review/QC ADaM datasets programmed by STAT team - Review draft and production statistical output, responsible for quality and consistency of output across multiple cycles - Recommend statistical methodology to analysis of clinical trial data - Author statistical reports, contribute to the Clinical Study Report, abstracts, manuscripts and other medical communication - Act as Biostatistician on DSMBs, SMCs and IDMCs - Trouble-shoot complex statistical issues and make recommendations - Assure quality of personal work.