In general, to provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies.  Specifically, to determine analysis and data presentation specifications for programmer analysts.  Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports and final reports.  Responsible for ensuring that the biostatistics portion of project timelines are met with superior quality deliverables.

Knowledge of the biostatistical, programming, and data management aspects of the clinical research service industry; Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research; Experience with the management and statistical analysis of data obtained from Phase I – IV clinical trials; Ability to synthesize results in graphic, oral, and written reports; Experience using SAS (including data manipulation) and other software packages such as SPSS, S-Plus; and ability to plan long-range needs while assuming responsibility for daily details with a high degree of accuracy.

• BS in one of the life sciences and seven years related experience; or MS in Mathematics or Biostatistics with four years related experience; or doctorate-level degree in Statistics or Biostatisticas with one year related experience. 
• Data handling or analysis experience required.

Responsible for monitoring PharmaLinkFHI clinical trials to ensure that investigators are conducting the research within requirements of the clinical protocol, that research is conducted in accordance with applicable federal regulations and guidelines, that data quality on initial review meets acceptable clinical standards, and the rights and safety of human subjects involved in a clinical study are protected.

Knowledge of clinical research process and medical terminology; Eighteen months experience in monitoring and/or coordinating clinical trials preferred; experience in a clinical setting preferred; Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions; Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor entry level CRAs; Understand electronic data capture including basic data processing functions and understand current GCP/ICH guidelines applicable to conducting clinical research

• BS/BA in one of the life sciences with a minimum of two years of related experience preferred; MS/MA with a minimum of 12 months of related work experience preferred. 
• Experience coordinating and/or monitoring clinical trials required. 
• Computer literacy and knowledge of electronic data capture preferred. 
• Must possess strong verbal and written communication, interpersonal, and organizational skills. 
• Must be able to travel domestically and internationally approximately 50%-70%.

Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities.  Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial.  Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by PharmaLinkFHI and its clients.

Work with Project Manager to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP; Coordinate site management activities; Coordinate and oversee daily operations of clinical monitoring team; Manage project milestones and proactively address deficiencies; and manage CRA performance.

• BS/BA in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience. 
• Previous experience in personnel management within a scientific/clinical environment preferred.
• At least 3 years as a Clinical monitor, as well as experience in data handling or analysis also required.  Excellent verbal and written communication skills required.

Responsible for the successful planning, implementation and execution of contracted clinical activity. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by PharmaLink FHI and sponsors.

Supports the department director in development of functional training, definition of standards and employee evaluation.

• BS/BA in one of the life sciences with a minimum of three years of direct clinical trial experience in a CRO or Pharmaceutical with at least three years managing clinical studies; or equivalent level of education and experience.  
• Previous experience in managing people within a scientific/clinical environment is required.
• Clinical Monitoring or Data Management experience is preferred.