Gaithersburg, MD 20697
Washington DC area
Nihar Parikh, [email protected]
Our client a global biopharma, has an opening for a Principal Biostatistician to provide statistical expertise, clinical trial design, and analysis for clinical development programs. Provide modeling and statistical oversight and standards for study level work. Seeking candidates with experience in Oncology, Respiratory, Cardiovascular, or other disease areas.
-Oversee clinical development plans, SAP, and study design.
-Support protocol development and provide strategic guidance for global project teams.
-Lead regulatory submissions, provide regulatory strategy and interact with the FDA.
-Support clinical study report writing and clinical publications as well as compound development across major therapeutic areas.
-Apply statistical principles and provide solutions to problems in drug research.
-Provide statistical oversight to vendors, mentor staff and work with cross-functional teams.
-MS/PhD in Biostatistics, Mathematics, or related field and 5+ years of experience in Pharma/Biotech as a study Statistician.
-Background in therapeutic areas such as Oncology, Respiratory, Cardiovascular, etc.
-Experience in regulatory submissions, clinical development and statistical analysis plans.
-Experience in program design, clinical study reports, statistical protocol and regulatory interactions.
-Experience in SAS/R programming.
-Strong interpersonal and communication skills.
Smith Hanley Associates is a niche recruiting agency. #GD