This is a remote, full-time freelance consulting role. Roles and Responsibilities Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol. Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality. Demonstrates strong understanding of ICH guidelines, as applicable to statistics. Works with the project management group to ensure timelines are appropriate given the scope of the project. Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client. Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers. Takes initiative to suggest and implement departmental process improvements. Excellent understanding of SDTM and ADaM dataset structures and ensures standards are incorporated correctly into current projects. Communicates competently and independently with client to coordinate the statistical and programming considerations of the project. Generates and reviews randomization schedules per the protocol and randomization specifications. Works with programming team to provide definitions for analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs). Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements. Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial. Demonstrates excellent internal and external leadership skills for projects. Leads projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client. Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets. Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP. Trains via self-study and self-practice independently and explores advanced topics related to biostatistics and/or drug development. Creates statistical training exercises, trains new biostatisticians, and serves as a mentor. Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician. Is familiar with and stays current with the latest industry practices and updated regulatory guidelines. Responsible for the statistical considerations in FDA submissions for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), including but not limited to ISS/ISE SAP, data integration plan and oversight of all integrated analyses. Represents self and company in a professional manner and in line with core company values. Practices excellent internal and external customer service, communication, and teamwork. Supports objectives and improvement efforts within department and organizationally. Complies with all applicable policies, procedures, and training requirements. Additional tasks as assigned by manager. Requirements College graduate in statistical discipline, computer science or related field, or related experience. Strong hands-on experience with clinical trial and pharmaceutical development. Strong programming and logic skills. Experience in pharmaceutical or CRO industry preferred. Strong SAS programming, SAS base, SAS macro experience. Thorough knowledge and understanding of clinical data preferred. Familiarity with graphical software (e.g., SigmaPlot). Excellent organizational and communication skills. Strong experience with data and production of TLGs. Excellent scientific writing skills. Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques. Familiarity with ISO 9001:2015 and ISO 27001:2013 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
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