Senior Biostatistician

This is a remote, fulltime 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 mínimal 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 team work
- 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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