Principal DMC Biostatistician
- Develop and review input for DMC activities (charter, statistical analysis plan, mock shells, specifications, analysis, programming and validation, DMC meetings, meeting minutes).
- Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor.
- May serve as functional lead on DMC project teams.
- Liaise with client/DMC for clarification on any technical decisions and propose most efficient, successful solutions.
- Interact and coordinate with client staff and DMC members.
- Participate in project team meetings and DMC meetings on a regular basis.
- Provide statistical advice in project team setting.
- Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks.
- Stays current regarding requirements to ensure quality control and audit readiness of all assigned biostatistics deliverables as well as accuracy and reliability of statistical analysis results.
- Accurately review and report project forecasting and actual hours as scheduled per agreed scope for biostatistics tasks.
- Understand and follow all relevant SOPs.
- Understand and adhere to project specific clinical protocols.
- Mentor Biostatisticians.
- May coordinate activities of other personnel.
- Master’s degree or PhD in Biostatistics, Statistics, or related field.
- With PhD, a minimum of 5 years of industry experience, with an MS a minimum of 7 years of industry experience.
- SAS programming skills; R a plus.
- Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
- Prior DMC experience required.
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