The Senior Biostatistician is a proven leader in clinical program management in the clinical research industry, and manages, executes and reports on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables. Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.
Provides statistical input into protocol and CRF development.
Designs the randomization process for protocols.
Communicates with clients regarding study protocol and statistical analysis uses.
Reviews statistical analysis plans.
Provides input to SOPS, general standardization efforts.
Collaborates effectively with team members (internal and external).
Reviews and approves RFPs from various vendors.
Participates in the ongoing quality assurance of all statistical vendors by performing vendor audits, review of vendor SOP’s and quality control during project.
Performs full quality control of all data are received from outside statisticians to assure 100% quality.
Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
Manages and executes the overall project scope, budget, and timelines. Identifies project success factors for analysis, reporting, and tracking.
Manages resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.
Leads the development of study specific protocols, consent forms, and other trial related materials as required.
Ensures 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.
Prepares and reviews clinical data for analysis. Manages relationships with consultants to provide adequate support and services for data collection and analysis.
Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. Monitors adherence to project contract and budget.
Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
Supports the management and oversight of CROs and other clinical study related vendors.
Provides therapeutic training and guidance to clinical team.
Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.