Job Purpose / Summary: Represent Biostatistics on CTI study teams, report study status to Biostatistics management, and perform, or oversee performance of, all Biostatistics-related activities while ensuring the integrity of the data and analysis by adhering to all applicable regulatory requirements and CTI Standard Operating Procedures (SOPs).

What You'll Do:

• Assist with the development and modification of department SOPs and work instructions
• Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians
• Develop study bids and changes in scope for Biostatistics tasks in response to prospective client’s
• request for proposals (RFPs).
• Attend and present the Biostatistics study execution tasks at capabilities presentations.
• As the lead Biostatistician on the studies to which you are assigned, perform, or oversee the following tasks:
  • Act as primary statistical contact for internal and external project team members
  • Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines
  • Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management
  • Review case report forms (CRFs) and completion instructions
  • Give input to database design and data edit considerations necessary to collect and clean data
  • Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
  • Develop or review program specifications – SDTM and ADa M dataset specifications and mock tables, listings, and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
  • Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
  • Review programming of other team members
  • Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
  • Plan and design clinical studies, including:
    • overall study design development
    • outcome / endpoint determination
    • power analysis / sample size estimation reports
    • randomization and blinding procedures development
    • statistical methods section development in the protocol
  • Develop or review Randomization Plans, and randomization programs or lists
• Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
• Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers
• Maintain accurate records of all work performed and ensure all relevant statistics documents are filed in the e TMF per the project-specific e TMF Plan
• Provide input to and participate in departmental meetings

What You'll Bring:

• At least 5 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience
• Master’s degree in Biostatistics, Statistics, or related field
• CDISC, SDTM, and ADa M dataset mapping experience
• BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) preferred
• Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferred
• Experience providing statistical consulting to internal/external clients preferred

About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com