Sr Statistical Programmer

What You'll Do:

• Assist with the development and modification of department SOPs and work instructions

• Assist with training new statistical programmer employees; mentor and assist junior level programmers

• Assist with the development of study bids and changes in scope for Statistical Programming tasks in response to prospective client’s request for proposals (RFPs)

• Develop macros for department use that maximize efficiency and quality

• As the lead statistical programmer on the studies to which you are assigned, perform or oversee the following tasks:

• Act as primary statistical programming contact for internal and external project team members

• Work with the lead statistician to manage projects to ensure statistical programming tasks are performed within the entire project timeline. Keep Statistical Programming management aware of changes to project timelines.

• Proactively identify and communicate changes in scope to the clinical project manager and Statistical Programming management

• Provide SDTM naming conventions for database build specifications

• Develop, or oversee the work of others to develop, SDTM dataset specifications and assist with the development of ADaM dataset specifications and table, listing and figure (TLF) shells needed to perform the analysis defined in the Statistical Analysis Plan (SAP)

• Review/develop SDTM-annotated CRFs

• Perform the statistical programming to create SAS dataset deliverables, including SDTM and ADaM datasets, per dataset specifications

• Review Open CDISC findings and generate Reviewers Guide and Define.xml files

• Review the SAP and the TLF shells, and provide feedback to the statisticians

• Perform the statistical programming to create TLFs per mock TLF shells

• Perform data transfer activities between SAS and various databases and data file formats for internal team members (e.g., Clinical Data Management, Safety) and external clients (e.g., third party vendors, central labs), including file reconciliations

• Perform statistical programming to review data for protocol adherence, coding consistency and plausibility

• Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice/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 statistical programming 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 5 years of related statistical programming experience in either a pharmaceutical or CRO environment or other relatable statistical programming experience

• Bachelor’s degree in Statistics or Biostatistics or demonstration of excellent technical ability in statistical programming procedures

• CDISC SDTM and ADaM dataset mapping experience

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com