Penfield Search Partners
Contact: John Mailey – 203.955.1312 – firstname.lastname@example.org
Job Description: Biostatisticians work collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of company clinical data in efficiently achieving regulatory, scientific and business objectives.
- Collaborate with outside experts and internal colleagues to present and publish trial results and statistical analysis within and outside of the Company.
- May specialize within a particular Therapeutic Area/indication or technical area to serve as a Company-wide resource.
- Has knowledge of regulatory requirements to ensure the Company meets regulatory, scientific, and business objectives.
- Oversees training programs for the job family and provides strategic direction for the group.
Job Responsibilities and Skills:
- Works collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
- Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives; collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company, negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles.
- Is expected to oversee and contribute to the completion of all technical and operational statistical activities for multiple development programs for a compound or equivalent through management of internal and external resources.
- Provides overall leadership for a departmental strategic initiative.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Has understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company.
- Can make effective decisions where information is limited or solutions may produce unpleasant consequences in the short term.
- Able to set up and influence collaborations with external academic or government organizations to extend visibility or business need of the company.
- Can set up data monitoring committees for clinical studies.
- Able to identify the most critical aspects of a problem/issue.
- Can use competitive intelligence to influence clinical development strategies.
- Proven ability to directly supervise personnel.
Education and Experience:
- 12 years of industry experience in the statistical analysis of biomedical data using SAS software and a BS degree in Biostatistics or equivalent.
- 10 years of industry experience in the statistical analysis of biomedical data using SAS software and an MS degree in Biostatistics or equivalent
- 8 year of industry experience in the statistical analysis of biomedical data using SAS software and a PhD degree in Biostatistics or equivalent.