Senior Biostatistics Consultant

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

This is a project-based consulting position that could turn into fulltime for the right candidate. Some of responsibilities may include:

• 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 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
• Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses
• 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
• Proficiency with MS Office applications
• 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