job summary: Sr Biostatistician Job Responsibilities
Education & Qualifications
- Act as the core project team lead to coordinate and manage all statistical project activities.
- Provide statistical liaison with the client.
- Provide statistical input for protocol and CRF development.
- Prepare statistical analysis plans.
- Perform validation and statistical quality checks on computer-generated output to verify accuracy.
- Review works performed by others and provide recommendations for improvement.
- Prepare and review key portions of the integrated clinical/statistical report, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy and safety results.
- Attend regulatory agency meetings and respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
- Undertake statistical consultancy for sponsor companies.
- Follow departmental SOPS, OGs and relevant regulatory guidelines (e.g. ICH).
- Extensive experience in statistical analysis of clinical or consumer health trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians
- Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis
- Proficiency in SAS programming
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Ability to travel may be required
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
location: Raleigh, North Carolina
job type: Contract
salary: $44.74 - 52.63 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.