DMC Biostatistician II

The Biostatistician II is expected to be on a path toward developing understanding of advanced statistical methods and innovative statistical approaches. 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. It is the intention that this role develops into a Lead DMC Biostatistician.

Responsibilities:

• Contribute statistical knowledge to studies in project team setting.

• Implement a wide variety of statistical methodologies.

• 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.

• Liaise with client/DMC for clarification on any technical decisions and propose most efficient, successful solutions.

• Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks.

• Attend relevant project meetings and work closely with other internal and external leads.

• Coordinate production of DMC reports among biostatisticians, programmers, and project management teams.

• Ensure blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related standard operating procedures (SOPs) and regulatory requirements.

• Assist in project documentation.

• Participate in project team meetings and DMC meetings on a regular basis.

• Understand and follow all relevant SOPs.

• Understand and adhere to project specific clinical protocols.

Qualifications:

• Master's degree or PhD in Biostatistics, Statistics, or related discipline.

• With PhD, a minimum of 1 year of industry experience, with MS a minimum of 2 years of industry experience. 

• Strong knowledge of statistical methodology and analytic techniques.

• SAS or R programming skills a plus.

• Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.

• Prior DMC experience required.