Havard Clinical Research Institute

Project Biostatistician

Are you looking for more balance in your life? Do you want to work for a company which values the quality of life for its employees? The consider working for The Harvard Clinical Research Institute, Inc. (HCRI). HCRI is an applied clinical science center that provides integrative resources to support clinical trials and other clinical research.

Working within the unique world-class patient care and research environment of the Harvard Medical School and affiliated institutions, we uphold the highest academic and ethical principles for patient-based research. HCRI facilitates interaction of existing scientific resources within its academic community and broadens interaction among clinical researchers and sponsors of research around the world. HCRI is continuing to expand its leadership presence and currently has an opening for a Project Biostatistician.

The Project Biostatistician will be responsible for ensuring that studies are correctly designed, data properly captured, projects analyzed using appropriate statistical methods and the results are clearly presented to support domestic and international regulatory submissions.

Job Activities:

  1. Represent Biostatistics Department on Trial Design and Development Team and HCRI Project Team

  2. Serve as contact with sponsors for statistical aspects of assigned projects

  3. Monitor timelines and resources for assigned projects

  4. Prepare statistical sections of protocols including sample size calculations

  5. Review protocols and CRFs for assigned projects

  6. Prepare detailed statistical analysis plans

  7. Conduct statistical analyses on assigned projects

  8. Perform validation and quality control of data displays that show inferential statistics

  9. Review and/or write statistical documents generated in support of assigned studies

  10. Review integrated clinical/statistical reports to ensure adequate presentation of statistical methodology and interpretation of results.

Requirements:

Education:
Required: MS/PhD preferred in Biostatistics or related area

Travel: Limited

Qualifications

  1. Individual must be detail oriented, and have strong organization and prioritization skills.

  2. Must have advanced computer skills as well as leadership, decision making, and strong communication skills.

  3. Ability to handle multiple projects and stressful situations.

  4. Technical expertise in biostatistics with experience with SAS programming and strong knowledge of regulatory requirements is needed.

  5. Must have demonstrated experience in the clinical research process, trial design, development of protocols/analysis plans.

  6. Thorough understanding of the clinical trial and drug development process and the role the CRO plays in that process.

  7. Excellent verbal and written communication skills

  8. Willingness to relocate to Boston area

  9. Possess legal authorization to work in the United States

Harvard Clinical Research Institute offers an intellectually stimulating environment in which the encouragement of professional development and education promotes personal excellence and enhances the value of the institute.

HCRI is also committed to excellence and competence and offers its employees a full range benefits including subsidized parking or discounted T passes; health, dental and vision insurances; 3 weeks paid vacation; flex time, personal / sick time; 401K with match; pension plan (money purchase plan); short and long term disability insurances; tuition reimbursement; career development opportunities; professional training; and more!
Please send resumes to Human Resources:
hcrijobs@hcri.harvard.edu or fax 617.632.1343.
Or mail to:
Harvard Clinical Research Institute
930 Commonwealth Ave. West, 3rd floor
Boston MA 02215

HCRI is an equal opportunity employer that values the strength diversity brings the workplace.