Senior Biostatistician; Clinical Trial
Job in
Covington, Kenton County, Kentucky, 41011, USA
Listed on 2026-08-28
Listing for:
CTI Clinical Trial and Consulting Services
Full Time
position Listed on 2026-08-28
Job specializations:
-
IT/Tech
Data Engineering, Data Scientist, Information Security & Data Protection, Data Analyst
Job Description & How to Apply Below
- 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 ADaM 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 eTMF per the project-specific eTMF Plan
- Provide input to and participate in departmental meetings
- 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 ADaM 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,…
Position Requirements
10+ Years
work experience
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