Job Description

About the job

Perform or assist with 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

• Review case report forms (CRFs) and completion instructions
• Give input to database design and data edit considerations necessary to collect and clean data
• Assist in the development of Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
• Assist with the development of program specifications – SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
• Assist with the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
• Assist with the development or review of statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
• 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 eTMF per the project-specific eTMF Plan
• Provide input to and participate in departmental meetings

REQUIRED EDUCATION AND EXPERIENCE

• Master’s degree in Biostatistics, Statistics, or related field
• CDISC SDTM and ADaM dataset mapping experience
• Knowledge of medical terminology and drug nomenclature
• Knowledge of the drug development and clinical research process (Phase I-IV clinical trials), and real-world evidence studies process
• Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities
• Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease

COMPETENCIES

• Excellent verbal and written communication skills
• Strong motivation to produce high-quality deliverables with an attention to detail
• Knowledge of statistical software packages, including SAS
• Knowledge of appropriate usage of statistical tests
• Ability to work independently and be self-motivated
• Ability to work effectively and successfully in a team environment
• Ability to manage responsibilities across multiple simultaneous projects

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

Why CTI?

• Advance Your Career– We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team– We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact– We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an@ctifacts.comemail address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• • We will never communicate with you via Microsoft Teams or text message.
  • We will never ask for your bank account information at any point during the recruitment process.