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
What You'll Do:
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
What You’ll Bring:
At least 4 years of related biostatistics experience in either 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
BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) preferred
Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferred
Experience providing statistical consulting to internal/external clients preferred
About CTICTI 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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