Will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation. This person will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
ResponsibilitiesParticipate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
Collaborate with cross-functional team members to meet study any recurring report timelines.
Support the development and implementation of study protocols.
Review and provide input to data capture systems and participate in their validation.
Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
Respond to statistical questions from regulatory agencies.
QualificationsMS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 7 years of experience in pharmaceutical or biotechnology industry.
PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
Knowledge of drug development regulations pertinent to statistical analysis.
Knowledge of the oncology or hematology therapeutic area is preferred.
Bayesian and adaptive design experience is preferred.
Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
Excellent writing and communication skills.
Demonstrated leadership abilities and excellent interpersonal skills.
