APELLIS PHARMACEUTICALS, INC. – $101,026.00/Year

PhD in Statistics, Biostatistics or Mathematics and a minimum of 3 years of postgraduate experience as a biostatistician in the clinical trials setting in the pharmaceutical industry.br br Experience, which may have been gained concurrently, must cover all phases of drug development and include the followingbr br 3 years of experience developing SAS programs and preparing data displays;br 3 years of experience in the application of statistical methods longitudinal data analyses, Bayesian method, adaptive design, Simulationsbr 2 years of experience writing statistical sections of clinical studytrial protocols, developing statistical analysis plans SAPs, and review and oversight of Case Report Forms CRFs design and specification for Analysis Data Model datasets ADaMs.br 2 years of experience working with study teams, authoring TFL specifications and producing TLFs for Data Monitoring Committees, and disclosure results reporting to FDAEMEA.br br Qualified candidates for consideration will be able to demonstrate the followingbr br Expertise in the application of advanced statistical methodologies to improve efficiency and sensitivity of data collection;br Familiarity with ICH guideline, FDAEMAother regulatory authority guidance;br Sound knowledge in CDISC including SDTM, ADaM, and controlled terminologies;br Strong oral and written communication skills and ability to work collaboratively with crossfunctional teams to meet study and product deliverables and timelines;br Prior authorship of regulatory documents or scientific documents for publicationbr br This position is fully remote, working within the continental U.S., and reporting to Apelliss headquarters in Waltham, MA.br br br Note to Section I.c., Recruitment Information The recruitment advertisements were posted for Apellis Pharmaceuticals, Inc.s headquarters office location in Waltham, MA. An additional recruitment advertisement was also posted in a national newspaper USA Today, since the position is fully remote and the candidate may work anywhere in the continental U.S.