We currently have an opening for a Staff Biostatistician in our Edison, New Jersey location. This person provides statistical guidance on range of topics and regular project updates; acts as a statistical consultant in regulatory and clinical forums and meetings across all projects and programs; seeks out and tests new statistical software; and seeks to broaden the utilization and acceptance of departmental expertise and support in areas outside of Clinical Development and Regulatory Affairs (e.g., Marketing, Preclinical, and Toxicology). This position has no direct reports.
You will Serves as Project Biostatistician; collaborates globally to ensure worldwide acceptance of statistical design and analyses.
Ensures that study design, protocol preparation, and statistical analysis methodologies meet study/project objectives, and are in compliance with regulatory guidances.
Demonstrates Daiichi-Sankyo core competencies at individual contributor level; exhibits Daiichi-Sankyo values.
Ensures accuracy of all statistical analyses and interpretation in clinical study reports and of timelines for deliverables within assigned projects.
Active participant in regulatory agency meetings and responds to regulatory requests and questions.
Establishes the consistency of study designs, parameter algorithms and definitions, analyses and calculations, and reporting formats for all studies within assigned project.
Identifies, tests, and validates new statistical software.
Seeks to broaden the utilization and acceptance of departmental expertise and support in cross-functional areas throughout Daiichi-Sankyo.
Leads the preparation of the project ISE and ISS through development of statistical analysis plans for same.
Acts as a statistical consultant to Senior Management and outside consultants to resolve statistical issues and to develop projects.
Addresses specific statistical issues in the design of studies from Proof of Concept to Phase IV.
Establishes novel statistical study designs and methodologies for enhancing early stage decision making.
Qualified candidates will have MS or PhD in Statistics, Biostatistics, or Mathematics. PhD + 8 yrs or MS + 10 years of pharmaceutical industry experience; 5+ years of Oncology experience; full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, coding techniques, and statistical software.
Excellent oral and written communication skills; project planning skills;
demonstrated experience in analyzing clinical trial data; priority setting skills; multi-tasking skills; problem solving skills; eye for detail; exercise good judgment; and works well within team framework.
Comprehensive project management skills. Demonstrated competency in SAS.
Regular attendance at IDT Meetings is necessary; experience in managing CROs and external vendors.
Must be willing to travel 10% of the time.
- PLease apply online at: http://www.hirelifescience.com/seeker_jobs.aspx?jobsID=480871&jobtitle=Staff%20Biostatistician%20-%20Oncology
Staff Biostatistician - Oncology job in Edison, NJ