Covance Senior Biostatistician in Wilmington, North Carolina
Responsible for providing a statistical analysis service for Covance studies, providing advice and assistance in the design of those studies. Providing a contract statistics service to clients, including advice on design and appropriate statistical techniques.
Duties and Responsibilities:
Assume the role of Study Statistician for some studies, particularly non-standard / contract type studies.
Development and review of Statistical Analysis Plans and Statistical Contributions, to include statistical methodology, statistical programming procedures, definition of derived variables, data handling rules and mock-ups.
Statistical analysis of clinical trial data and related decision making.
Responsible for statistical input to clinical study, pharmacokinetic and statistics reports.
Preparation of randomization specifications and the generation of randomization schedules.
Verification of randomization components (specification and schedule).
Provides input into the planning activities related to the preparation of, distribution of and access to randomization and unblinding information as required.
Perform sample size calculations as required.
Maintain project administration files with regard to all documents produced by Biostatistics, including associated review, QC and project tracking information and internal and external communications.
Review of protocols, providing a statistical advice service for internal and external clients.
Scheduling of clinical statistical work to meet required deadlines. Ensuring that projects are completed in a timely and accurate manner.
Liaison with internal and external clients, as required.
Perform QC of all efficacy and safety datasets and data displays.
Review of Clinical Study Reports.
May authorise final reports as one of the Covance signatories.
Perform independent peer review of statistical deliverables.
Interpersonal and effective communication skills. Co-operative and team orientated.
Assure quality of personal work.
Training of other members of staff within the department in statistical methods and programming techniques.
May train scientists and medical staff in statistics, as required.
Maintaining an up to date knowledge with FDA guidelines and in new statistical methods, implementing them when necessary.
Provide statistical support to SAS Programmers.
May provide support for Data and Safety Monitoring Board (DSMB), ensuring maintenance of appropriate blinding.
Promoting a professional attitude at all times both internally and externally and dressing accordingly in an appropriate manner.
Selection and induction of staff for which he/she is directly responsible, providing training, regular status meetings, setting objectives and monitoring progress through PMD.
Contribute to the review and amendment of departmental processes and supporting documentation.
May contribute to proposal activities and client presentations as needed.
Performs any other duties as assigned.
- Masters degree in Statistics or related field, preferably with a strong medical statistics
Required: USA and Europe
Skilled in the use of PC based statistical packages (e.g. SAS) and general computer operation.
Proven skills in the use of PC based statistical packages (especially SAS) in clinical research.
- 4-6 years related experience or PhD degree in Statistics plus 1-3 years of related experience considered.
Job Number 2019-27333
Job Category Biostatistics/Programming
Position Type Full-Time
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