Senior DMC Biostatistician

JOB DESCRIPTION

The Senior Biostatistician provides input into statistical aspects of clinical trials and DMCs including analysis plans and reports, is involved in programming and quality control of analysis datasets and statistical outputs and may provide statistical advice to clients. The Senior Biostatistician is expected to have a thorough understanding of advanced statistical methods and develop an understanding of innovative statistical approaches (e.g., simulations, adaptive designs, Bayesian statistics). The Senior Biostatistician is also expected to have a thorough understanding of the DMC process and may assume the functional lead role within a designated DMC project team, involving facilitation of DMC meetings, awareness and active monitoring of project budgets, hours budgeted/spent, timelines, and will be actively contributing to systematic regular project status reviews.

We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.

RESPONSIBILITIES

Responsibilities:

• 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.

QUALIFICATIONS

Qualifications:

• Master’s degree or PhD in Biostatistics, Statistics, or related field.
• With PhD, a minimum of 3 years of industry experience, with MS a minimum of 5 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.