Senior Biostatistician (Clinical Trial Experience Required)

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:
o overall study design development
o outcome / endpoint determination
o power analysis / sample size estimation reports
o randomization and blinding procedures development
o 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 degr...