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

• 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 tools
  
  Knowledge 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