Careers at ESTERN Medical


Business Title

Regional - Biostatistician

Requisition ID

EM-R-Biostat-1101

Job Category

Clinical Research

Locations

USA, Germany

Job Description

Duties and Responsibilities:

The Biostatistician Acts as lead statistician on projects of moderate to large size and complexity; support lead statistician on very large, complex studies. May have staff management and/or project management responsibilities. Also, writes statistical reports. Aid in the development of protocols.

Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.

Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team. Include P&L, Revenue and/or Budget responsibilities (if applicable)

Assigned tasks related to the development of less-experienced staff within the department.

Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups.

Responsible for Biometrics deliverables within assigned projects.

Perform QC of all efficacy and safety datasets and data displays.

Statistical analysis of clinical trial data and related decision-making.

Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of ESTERN Medical signatories.

Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input; approves as signatory.

Provide statistical input into design/review of format of CRFs.

Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.

Take responsibility for overall status and quality of Biostatistics’ project documentation, including maintenance of hardcopy and electronic files.

Independent peer review of statistical deliverables, eg, protocols, Statistical Analysis Plans, Tables Figures and Patient Data Listings, statistical reports, Clinical Study Reports.

Provide support for DMCs, ensuring maintenance of appropriate blinding.

SAS programming and related activities for the presentation and analysis of clinical trial data.

Contribute to review and amendment of departmental processes and supporting documentation.

Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.

Provision of technical solutions and advice to ESTERN Medical staff and to clients on statistical methodology and principles.

Contribute to proposals activities and client presentations.

Contact with client across multiple disciplines.

Represent the department during project-driven client audits.

Carry out all activities according to appropriate ESTERN Medical SOPs, working within the framework of the Quality Management System and to GCP.

Perform other duties as requested by management.

English Written & Verbally

Education/Qualifications

Masters or PhD in Statistics or related field

Experience

5 years experience in pharmaceutical or CRO industry

Qualified candidates should Email their resume, cover letter and desired salary to:

ESTERN Medical, Human Resources hr@esternmedical.com

ESTERN Medical is an Equal Opportunity Employer