Senior Biostatistician (Clinical Trial Experience Required)

CTI Clinical Trial and Consulting Services•Covington, KY

5d•Hybrid

About The Position

CTI Clinical Trial and Consulting Services is seeking a Senior Biostatistician with clinical trial experience. This role involves assisting with the development and modification of department SOPs and work instructions, training new Biostatistics employees, and mentoring junior biostatisticians. The Senior Biostatistician will also develop study bids and present Biostatistics capabilities. As the lead biostatistician, responsibilities include acting as the primary statistical contact, managing projects, reviewing CRFs, contributing to database design, developing and reviewing SAPs and IAPs, developing and reviewing program specifications (SDTM, ADaM, TLFs), performing statistical analysis, validating programs, and reviewing the programming of other team members. Additionally, the role involves developing or reviewing statistical methods and results sections for reports and publications, planning and designing clinical studies (including study design, endpoint determination, power analysis, randomization, and blinding), and developing or reviewing Randomization Plans. All activities must be carried out according to CTI SOPs and GCP/ICH guidelines, maintaining accurate records, and participating in departmental meetings.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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