Gaithersburg, MD 20697
Washington DC area
Nihar Parikh, [email protected]
Our client has an opening for a Principal Biostatistician to provide statistical expertise, clinical trial design, and data analysis for clinical studies within multiple therapeutic 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.
-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.
-Background in Cardiovascular, Oncology, Respiratory, Diseases or similar therapeutic area.
-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.