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.