Associate Director, Biostatistics
Summary of Essential Job Functions
Provide statistical support to clinical development plans, strategies, endpoint selection, study design, scientific publications, and regulatory meetings
Collaborate with the clinical team in the design, analysis, and reporting of data in clinical trials
Lead biostatistics activities on a NDA filing
Responsible for the development of Statistical Analysis Plan and reporting results of statistical analyses, including information in the form of graphs, listings, and tables.
Provide statistical interpretation of results and explain statistical methodology to team members.
Provide statistical oversight to vendors, contractors, and consultants, and mentor junior staff
Represent biostatistics function or biometrics department in cross function teams
Provide leadership to Biometrics Functional Teams
Help head of biostatistics and biometrics leadership team to build up processes, tools, SOPs, and teams
PhD or Master in Statistics, Biostatistics, or relevant field.
Minimum 6 years of relevant experience for candidates with PhD and 8 years of relevant experience for candidates with a Master degree.
Solution orientated for complex clinical questions and translation of these to statistical hypothesis in study design.
Fluency with statistical analysis programing software.
Strong problem solving, decision making, project management, and leadership skills.
Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses.
Effective team player: willingness to go the extra distance to get results, meet deadlines, etc.
Excellent writing and oral communications skills.