We are currently recruiting for a Senior Biostatistician for a leading Clinical Research Organization.
Roles and Responsibilties:
Provide statistical input into Protocol and CRF development
Design the randomization process for clinical studies
Communicate with clients regarding study protocol and statistical analysis
Review statistical analysis plans and provide input
Provide input to SOPs, general standardization efforts
Collaborate effectively with team members (internal and external)
Perform full quality control of all data received from external statisticians to assure 100% quality.
Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
Manage and execute the overall project scope, budget, and timelines.
Ensure the appropriate development of all documents by CROs including but not limited to study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
Support the management and oversight of CROs and other clinical study related vendors.
Provide therapeutic training and guidance to the clinical team.
Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
PhD in Biostatistics or related discipline with 2+ years biopharmaceutical industry experience or MS in Biostatistics or related discipline with 4 years extensive industry experience will be considered
Experience with regulatory submissions and reimbursement activities
Proven knowledge and expertise in statistics and its applications to clinical trials
Fluent with statistical software including SAS and R
Ability to work independently and manage a team
Fluent in English (oral and written)
Excellent communication and presentation skills
Team player, with ability to work successfully across functions
Ability to lead and inspire Biometrics teams