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Biostatistician
Job Purpose/Summary
Perform or assist with all biostatistics-related activities while ensuring the integrity of the data and analysis by adhering to all applicable regulatory requirements and CTI Standard Operating Procedures (SOPs).
What You’ll Do
- As a Biostatistician on the studies assigned, assist with the following tasks:
- Review case report forms (CRFs) and completion instructions
- Give input to database design and data edit considerations necessary to collect and clean data
- Assist in the development of Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
- Assist with the development of program specifications – SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
- Assist with the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
- Assist with the development or review of statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
- 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 Bring
- Excellent verbal and written communication skills
- Strong motivation to produce high-quality deliverables with an attention to detail
- Knowledge of statistical software packages including SAS
- Knowledge of appropriate usage of statistical tests
- Ability to work independently and be self-motivated
- Ability to work effectively and successfully in a team environment
- Ability to manage responsibilities across multiple simultaneous projects
- Master’s degree in Biostatistics, Statistics, or related field
- Fluent in English
Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.
For that reason, we treat our team members with the respect they deserve, and our numbers show it:
- We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
- We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people – We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
- Our culture is unparalleled – We’ve received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.
Are you interested? Then we look forward to your electronic application.
