Biostatistician II (Clinical Trial Experience Required)

CTI Clinical Trial and Consulting Services•Covington, KY

1d•Hybrid

About The Position

As the lead Biostatistician on assigned studies, this role involves acting as the primary statistical contact for internal and external project team members. The position requires communication with Biostatistics management to maintain project budgets and timelines, review case report forms (CRFs) and completion instructions, and provide input to database design and data edit considerations. The role also includes developing or assisting in the development of Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs), developing program specifications (SDTM and ADaM dataset specifications and mock tables, listings, and figures - TLFs), and performing statistical analysis by programming derived datasets and TLFs. Validation of developer programs, development or review of statistical methods and results sections for reports, and assistance in planning and designing clinical studies are also key responsibilities. This includes study design, endpoint determination, power analysis/sample size estimation, randomization and blinding procedures, and statistical methods in protocols. The role also involves developing or assisting in the development of Randomization Plans and programs/lists. All activities must be carried out according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines. The Biostatistician is expected to maintain accurate records of all work performed and ensure 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.