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Senior Principal Biostatistician

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Company: Covance

Location: Portland, OR

Date Posted: June 27, 2014

Source: Covance

# Job PostingWe are seeking a Senior Principal Biostatistician to join our team in Princeton, NJ. Remote option is available.Responsibilities include:
* Act as statistical consultant for clients and Covance staff.
* Coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
* Provide training on biostatistics-related topics to other disciplines.
* Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and to communicate these clearly.
* Provide ongoing guidance and mentoring within the department to ensure thorough knowledge of the processes used and ongoing technical development.
* Provide support for special committees, e.g., DMCs, including input/review of charters, and ensuring maintenance of appropriate blinding
* Develop and maintain close working relationships with other disciplines, particularly those who interact closely with Biostatistics
* Identify and participate in the assessment and implementation of new technologies or of new applications for existing ones.
* Maintain ...

# Job PostingWe are seeking a Senior Principal Biostatistician to join our team in Princeton, NJ. Remote option is available.Responsibilities include:
* Act as statistical consultant for clients and Covance staff.
* Coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
* Provide training on biostatistics-related topics to other disciplines.
* Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and to communicate these clearly.
* Provide ongoing guidance and mentoring within the department to ensure thorough knowledge of the processes used and ongoing technical development.
* Provide support for special committees, e.g., DMCs, including input/review of charters, and ensuring maintenance of appropriate blinding
* Develop and maintain close working relationships with other disciplines, particularly those who interact closely with Biostatistics
* Identify and participate in the assessment and implementation of new technologies or of new applications for existing ones.
* Maintain awareness of new developments in discipline-related techniques, which may be applied to the management and reporting of clinical trial data.
* Supervision of less-experienced biostatisticians within project activities.
* Biostatistics lead for large global or other major projects.
* Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
* Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
* Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
* 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 Biostatistics deliverables within assigned projects.
* Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project.
* 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 Covance signatories.
* Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol 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.
* Determine documentation requirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
* Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
* 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.
* Contact with client across multiple disciplines.
* Contribute to proposal activities and client presentations.
* Represent the department during audits.
* Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
* Perform other duties as requested by management.# Education/Qualifications
* MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)# Experience
* Ten years of postgraduate experience in the application of statistics to clinical trials, preferably with at least one year of statistical project responsibility with a CRO.
* Interpersonal and effective communication skills.
* Cooperative, team-oriented and proactive.
* Self-motivation.
* Ability to motivate others.
* The ability to work to tight deadlines while maintaining high standards.
* SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis.
* Ability to adhere to strict guidelines and codes of practice.
* A good knowledge of the overall Clinical Trial process and of its application within Covance Clinical Development.
* Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
* Ability to explain statistical concepts to non-statisticians.
* Supervisory and organizational skills.
* A proactive approach to management of day-to-day activities and actions that may affect Covance as a business.
* A professional approach at all times.# EEO EmployerCovance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us. Covance is an E-Verify employer (US).
*

Business Title:

* Senior Principal Biostatistician
*

Requisition ID:

* 44685BR
*

Job Category:

* Biotechnology/Pharmaceutical
*

Locations:

* USA
- Atlanta, GA USA
- Dallas, TX USA
- Houston, TX USA
- Indianapolis, IN USA
- Madison, WI USA
- Memphis, TN USA
- Minneapolis, MN USA
- Nashville, TN USA
- Portland, OR USA
- Princeton, NJ
*

Shift:

* 1

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