Biostatistician II
Summary
Designs and executes statistical analyses for clinical trials, developing analysis plans, programming SDTM/ADaM datasets and tables/listings/figures, and serving as lead statistical contact for assigned studies. Works within GCP/ICH guidelines using SAS to support pharmaceutical or CRO research environments.
What You'll Do:
- 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
- Provide input to and participate in departmental meetings
What You'll bring:
- 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
About CTI
Advance Your Career - We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
Important Note
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