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Senior Biostatistician (Remote)

Covance 5/22/2019 5:50:08 AM
JOB ID: 31426 Category: Biostatistics Programming
King of Prussia, Pennsylvania



Job Overview

* 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.
* Perform QC/statistical review of all analysis 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 Covance 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.
* Supervision of less-Experience d biostatisticians within project activities.
* 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.
* Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
* Take responsibility for overall status and quality of Biostatistics' project documentation, including maintenance of hardcopy and electronic files.
* Provide statistical input into other disciplines' activities and participate in interdepartmental processes.
* Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
* Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
* Provide support for DMCs, ensuring maintenance of appropriate blinding.
* SAS programming and related activities for the presentation and analysis of clinical trial data.
* Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
* Contact with client across multiple disciplines.
* Assigned tasks related to the development of less-Experience d staff within the department.
* Contribute to review and amendment of departmental processes and supporting documentation.
* Contribute to proposals activities and client presentations.
* Represent the department during project-driven client 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.


* MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)


* 3 to 5 years of postgraduate Experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 5 to 8 years of postgraduate Experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
* Interpersonal and effective communication skills.
* Cooperative, team-oriented and proactive.
* Self-motivation.
* The ability to work to tight deadlines while maintaining high standards.
* SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
* Ability to adhere to strict guidelines & codes of practice.
* A good knowledge of the overall clinical trial process.
* Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.
* Ability to explain statistical concepts to non-statisticians.
* Organizational skills.
* An evident appreciation of the possible impact of day-to-day activities and actions on Covance as a business.
* A professional approach at all times.

Position Type: Full-Time

Location: King of Prussia, PA - Pennsylvania


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).