Biostatistician II (Clinical Trial Experience Required)

Join The CTI Team•Covington, KY

18h•Hybrid

About The Position

As the lead Biostatistician on the studies assigned, perform the following tasks: Act as primary statistical contact for internal and external project team members. Communicate and work with Biostatistics management to maintain the project budget and timelines. 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 assist in the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol. Develop 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. Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications. Assist in planning and designing 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 assist in the development of, 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, and quality deliverables to customers. Maintains accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan.

Requirements

2 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
Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities
Experience providing ability to explain complex statistical concepts to other project team members
BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication)
Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease

Responsibilities

Act as primary statistical contact for internal and external project team members.
Communicate and work with Biostatistics management to maintain the project budget and timelines.
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 assist in the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol.
Develop 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.
Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications.
Assist in planning and designing 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 assist in the development of, 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, and quality deliverables to customers.
Maintains accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan.