Covance Senior Biostatistician in Columbus, Ohio
These are permanent, salaried positions that can be done remotely from anywhere in the U.S. or Canada.
Essential Job Duties:
Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups.
Responsible for Biostatistics’ deliverables within assigned projects.
Perform QC/statistical review of all analysis datasets and data displays.
Statistical analysis of clinical trial data and related decision-making.
Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Covance signatories.
Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input; approves as signatory.
Provide statistical input into design/review of format of CRFs.
Supervision of less-experienced biostatisticians within project activities.
Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
Take responsibility for overall status and quality of Biostatistics’ project documentation, including maintenance of hardcopy and electronic files.
Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
Provide support for DMCs, ensuring maintenance of appropriate blinding.
SAS programming and related activities for the presentation and analysis of clinical trial data.
Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
Contact with client across multiple disciplines.
Assigned tasks related to the development of less-experienced staff within the department.
Contribute to review and amendment of departmental processes and supporting documentation.
Contribute to proposals activities and client presentations.
Represent the department during project-driven client audits.
Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
Perform other duties as requested by management.
Minimum Experience Required:
3 to 5 years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 5 to 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
Interpersonal and effective communication skills.
Cooperative, team-oriented and proactive.
The ability to work to tight deadlines while maintaining high standards.
SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
Ability to adhere to strict guidelines & codes of practice.
A good knowledge of the overall clinical trial process.
Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.
Ability to explain statistical concepts to non-statisticians.
An evident appreciation of the possible impact of day-to-day activities and actions on Covance as a business.
A professional approach at all times.
Minimum Education Required:
- MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)
A minimum of 10 years experience in provision of programming support for clinical trial management and reporting, preferably with at least 2 years of statistical programming responsibility with a CRO.
Strong project management skills and supervisory skills gained from at least 3 years leading large scale projects.
Job Number 2018-22937
Job Category Other
Position Type Full-Time
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