Biostatistician II, Clinical Trial Experience Required

Job Description:

• Serve as the lead Biostatistician on assigned studies
• Act as primary statistical contact for internal and external project team members
• Work with Biostatistics management to maintain project budgets and timelines
• Review case report forms and completion instructions
• Provide input on database design and data edit considerations
• Develop or assist with Interim Analysis Plans and Statistical Analysis Plans
• Develop SDTM and ADaM dataset specifications and mock tables, listings, and figures
• Independently program derived datasets and statistical tables, listings, and figures
• Validate corresponding developer programs according to department SOPs
• Develop or review statistical methods and results sections for statistical reports, clinical study reports, and publications
• Assist with clinical study planning and design, including study design, endpoints, power analysis, sample size estimation, randomization, blinding, and protocol statistical methods
• Develop or assist with Randomization Plans and randomization programs or lists
• Perform activities according to CTI SOPs, project conventions, and GCP/ICH guidelines
• Ensure timely, standardized, and high-quality deliverables
• Maintain accurate work records and file relevant statistics documents in the eTMF

Requirements:

• 2 years of related biostatistics experience in a pharmaceutical or CRO environment or other relatable statistical experience
• Master’s degree in Biostatistics, Statistics, or related field
• CDISC SDTM and ADaM dataset mapping experience
• Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities
• Ability to explain complex statistical concepts to other project team members
• BLA/NDA submission experience
• Regulatory representation, including meeting preparation/attendance and follow-up with regulatory communication
• Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease
• Clinical trial experience
• Ability to work according to Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
• Ability to use biostatistics SOPs and maintain accurate project records
• Ability to file statistics documents in the eTMF according to project-specific plans

Benefits:

• Structured mentoring program
• Leadership courses
• Tuition reimbursement
• Ongoing education and training
• Dedicated training department
• Generous health benefits
• Vacation packages
• Hybrid work from home opportunities
• Paid parental leave
• CTI Cares program
• Work-life balance support