Senior Biostatistician, Clinical Trial Experience Required

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

📋 Description

• Support the development and modification of departmental SOPs and work instructions.

• Provide training for new Biostatistics personnel and mentor junior Biostatisticians.

• Create study bids and scope modifications for prospective client RFPs.

• Present Biostatistics study execution activities during capabilities presentations.

• Act as the primary statistical liaison for both internal and external project team members.

• Oversee Biostatistics tasks within project timelines and communicate any changes to those timelines.

• Identify and relay changes in project scope.

• Review case report forms and completion guidelines.

• Offer insights on database design and data-edit considerations.

• Develop or assess Interim Analysis Plans and Statistical Analysis Plans.

• Create or evaluate SDTM and ADaM dataset specifications along with mock tables, listings, and figures.

• Independently program derived datasets and TLFs while validating the corresponding programs.

• Review programming work completed by other team members.

• Develop or evaluate statistical methods and results sections for reports, CSRs, and publications.

• Design and plan clinical studies, including endpoints, power analysis, randomization, blinding, and protocol statistical methods.

• Create or assess Randomization Plans and randomization programs or lists.

• Execute activities in accordance with CTI SOPs, project conventions, GCP, and ICH guidelines.

• Maintain precise work records and file statistical documents in the eTMF.

• Engage in departmental meetings.

⛳️ Requirements

• Minimum of 4 years of relevant biostatistics experience in a pharmaceutical, CRO, or similar statistical setting.

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

• Experience with CDISC, SDTM, and ADaM dataset mapping.

• Preferred experience with BLA/NDA submissions.

• Preferred experience in regulatory representation, including meeting preparation and attendance, as well as regulatory communication follow-up.

• Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology, and rare diseases is preferred.

• Preferred experience in providing statistical consulting to internal and external clients.

• Capability to operate within Good Clinical Practice and International Conference on Harmonization guidelines.

• Familiarity with biostatistics SOPs and project-specific conventions.

• Ability to independently program derived datasets and TLFs and validate corresponding programs.

• Experience with Interim Analysis Plans, Statistical Analysis Plans, Randomization Plans, SDTM, ADaM, and clinical study reports.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Tuition reimbursement opportunities.

• Continuous education and training.

• Dedicated training department.

• Award-winning company culture.

• Support for work-life balance.

• Comprehensive health benefits.

• Vacation packages.

• Hybrid work-from-home options.

• Paid parental leave.

• CTI Cares program.

• Support for career advancement.