At ProClinical, we are seeking an individual to fill the role of Biostatistics Lead - Senior Manager, based in Massachusetts. The successful individual will be responsible for providing project leadership in Biostatistics for one or more specific company products or a therapeutic area(s) as assigned. They will proactively assess problems and adapt solutions for the Biometrics department and will make decisions at the study level across a variety of studies.
- Develop standards across protocols in protocol development, analysis plans and file/report specifications.
- Perform statistical analyses, interpret statistical results, and prepare clinical study reports.
- Develop and maintain strong working relationships with collaborators from different disciplines across the organization.
- Engage with collaborators from different disciplines across the organization and leads statistical discussions in the team setting to reach agreement on statistical approaches.
- Review study set-up activities including but not limited to randomization, CRFs and data edits and serves as lead biostatistician on one or more projects.
- Review analysis of other study statisticians participating on their project for accuracy, consistency, and quality output.
Skills And Qualifications
- MS with minimum 4-6 years relevant experience or PhD with minimum 4 years relevant work experience.
- Strong written, verbal, and interpersonal communication skills.
- Conversant in SAS programming and other statistical software.
- Apply technical solutions to a wide range of problems.
- Working knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas.
- Working knowledge of regulatory guidelines/commercial needs relating to statistical analysis, study reports and statistical components of regulatory submission.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samuel Milam at (+1) 3475898643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.