Associate Director, Biostatistics
Basking Ridge, NJ
Location: Central New Jersey
Salary: $150,000 to $200,000
Contact: Nikki Quist, Nquist@smithhanley.com
Will provide leadership and guidance as the statistical expert on a project team accountable for all statistical aspects of project studies and submissions.
"Will assume leadership role for providing statistical support to a project team, including clinical development plans and individual protocols.
"Will develop statistical approaches applicable to project.
"Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations.
" Will ensure that planned statistical methods are applicable, and communicate statistical perspective to clients.
"Review SAP's and summaries for consistency with overall project objectives.
"Provide guidance on definition and documentation of derived variables needed and assume responsibility for accuracy of derived variables.
"consistency of data collection and analysis within project.
"Oversee execution of the statistical analyses.
" Act as company statistical representative at regulatory or external meetings.
"PhD or MS in statistics or related discipline with 8+ (10+) years of experience
"Thorough knowledge of pharmaceutical / biotech clinical development
"Ability to produce novel and near optimal clinical development plans
"Expertise in at least one therapeutic indication
"in-depth knowledge of key endpoints and regulatory guidelines
"Knowledge of regulatory guidelines on drug development, NDA submissions, and statistical practices.
"Understanding of the drug approval process ( Globally)
"Excellent communication skills
"Experience managing internal team and CROs
"Strong project management and leadership skills.