Principal Biostatistician

8 - 10 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
Virtual / Travel
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/21/17

Job Overview

As the Principal Statistician, you will join our Biometrics team in Princeton, NJ. Remote work is an option. The Principal Statistician will act as the Biostatistics lead for large global or other major projects. In addition, the Principal Statistician will have the opportunity to work on a wide range of therapeutic indications and different phases of clinical research. This is a supportive team environment that gives you opportunities to grow in your career. Additional Job Duties Include: • 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 statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Covance signatories. • Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project. • Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles. • Supervision of less-experienced 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. • 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. • Provide support for special committees, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding. • Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP. Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Education/Qualifications

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

Experience

• Five years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 8years 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. • 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.

Job Number 2017-13115

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