Biostatistician II, Clinical Trial Experience Required

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Act as the lead Biostatistician for designated studies

• Serve as the main statistical point of contact for both internal and external project team members

• Collaborate with Biostatistics management to uphold project budgets and timelines

• Review case report forms along with their completion instructions

• Provide insights on database design and data editing considerations

• Create or support the development of Interim Analysis Plans and Statistical Analysis Plans

• Generate SDTM and ADaM dataset specifications along with mock tables, listings, and figures

• Independently program derived datasets and statistical tables, listings, and figures

• Validate related developer programs in accordance with department SOPs

• Develop or review statistical methods and results sections for statistical reports, clinical study reports, and publications

• Aid in clinical study planning and design, covering aspects such as study design, endpoints, power analysis, sample size estimation, randomization, blinding, and protocol statistical methods

• Create or assist with Randomization Plans and randomization programs or lists

• Conduct activities in compliance with CTI SOPs, project conventions, and GCP/ICH guidelines

• Ensure the delivery of timely, standardized, and high-quality outputs

• Keep accurate work records and file relevant statistical documents in the eTMF

⛳️ Requirements

• A minimum of 2 years of relevant biostatistics experience in a pharmaceutical or CRO setting, or other applicable statistical experience

• Master’s degree in Biostatistics, Statistics, or a related discipline

• Experience with CDISC SDTM and ADaM dataset mapping

• Familiarity with ICH guidelines and regulatory requirements related to biostatistical activities

• Capability to articulate complex statistical concepts to other project team members

• Experience with BLA/NDA submissions

• Involvement in regulatory representation, including preparation for meetings and follow-up on regulatory communications

• Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver conditions

• Experience in clinical trials

• Ability to operate in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines

• Proficiency in utilizing biostatistics SOPs and maintaining accurate project records

• Competence in filing statistical documents in the eTMF in line with project-specific requirements

🏝️ 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

• Support for work-life balance