Senior Director, Biostatistics

Responsibilities acting as the statistical lead for one program or multiple programs providing technical leadership and statistical support on the design, conduct and execution of the clinical studies oversight of the statistics and programming team through an outsourced model partnering closely with the cross-functional teams and providing expert biostatistics input on development plans, regulatory interactions, and study design authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter analyzing and interpreting the clinical study results, and ensuring statistical integrity Requirements PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered A minimum of 8 years’ experience in progressive and relevant clinical trial experience Experience leading teams and working in a matrix organization Experience with blinded study designs and analyzing and interpreting patient reported outcome (PRO) data sets strongly preferred Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly Experience managing CROs and other data vendors Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a collaborative work culture Ability to keep pace in a fast-moving organization and navigate ambiguity Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment Knowledge and proficiency in SAS or R and other industry computational toolsKnowledge of CDISC standard including SDTM, ADaM Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance Experience in planning, running and documenting simulations, including clinical trial simulations Experience working on site and with remote teams Ability and willingness to travel up to 10% or as needed by the business #J-18808-Ljbffr