What are the responsibilities and job description for the Manager, Biostatistics position at CTI Clinical Trial Services, Inc?
Manager, Biostatistics
JOB PURPOSE / SUMMARY Responsible for Biostatistics project status reporting to the Assistant Director, Biostatistics. Serve as primary CTI Biostatistics contact with sponsors and represent Biostatistics on CTI project teams and/or oversee performance of other Biostatisticians in this role. Manage and perform all biostatistics-related activities for the studies assigned, 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:
- Manage the activities of Biostatistics team members to complete project deliverables on schedule and according to quality standards, requirements and the project budget from study start-up through archival
- Develop department SOPs and work instructions to ensure timely, quality deliverables to customers
- Ensure Biostatistics staff receives proper and adequate department SOP training, study / protocol-specific training, and job skills training
- Develop and conduct training for new Biostatistics employees; mentor and assist junior level biostatisticians
- Ensure adherence of Biostatistics staff to department SOPs
- Monitor the quality of work performed by biostatisticians and compliance with SOPs, and provide feedback to team
- Recommend alternative work processes to improve the quality or speed of customer deliverables and respond to questions on Biostatistics processes, timelines and quality
- Manage and communicate project progress, staffing, and resource allocation to the Assistant Director, Biostatistics, as needed
- Develop study bids for Biostatistics tasks in response to prospective client’s request for proposals (RFPs)
- Attend and present the Biostatistics trial execution tasks at capabilities presentations
- Perform the following duties for assigned studies and/or oversee performance of other Biostatistics staff:
- Act as primary statistical contact for internal and external project team members.
- 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 – 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
- Plan and design clinical trials, 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
- Provide input to and participate in departmental meetings
What You Bring
- 8 years of related biostatistics experience in either a pharmaceutical or CRO environment
- Master’s degree in Biostatistics, Statistics or related field required
- Strong CDISC SDTM and ADaM dataset mapping experience
Why CTI?
- We support career progression – We have a structured mentoring program to provide the support you need to move forward
- We value education and training – We provide tuition reimbursement, 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 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
- 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 – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
- 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 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
- 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
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