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
Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note- We will never communicate with you via Microsoft Teams or text message
- We will never ask for your bank account information at any point during the recruitment process
