Assoc Director, Clinical Research (Biostatistics) - Parsippany, NJ

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Matthew Masterson
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Assoc Director, Clinical Research (Biostatistics) - Parsippany, NJ

Under administrative direction, assists in the planning, coordination and execution of clinical research projects and programs for the clinical evaluation of new products. Supervises assigned department staff. This position will be based in Rockaway, NJ.

Carries out managerial responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws.

Oversees, directs, coordinates and prioritizes the daily activities of the assigned staff.

Contributes to the elaboration of product specific development plans including required activities and timing. Tracks progress against stated objectives.

Reviews individual clinical trial designs and protocols, and final clinical reports. Approves advertising material and informed consent templates. Reviews arrangements for conducting investigator meetings. Oversees the processing of serious adverse events and approves coding activities.

Approves individual study site selection and monitoring plan. Generates project-specific Investigator Brochures. Approves project specific CRFs and statistical analysis plans. Approves outside laboratory and other vendor selections. Oversees interactions with study sites.

Provides input on clinical selections in regulatory submissions, responses to FDA requests and pre-meeting packages. Generates safety reports including annual reports for regulatory submission. Oversees interactions with local and central institutional review boards. Reviews site audits and recommends corrective actions.

Reviews annual estimates and bids for outside clinical costs. Provides resource estimates to support projected clinical trials. Interviews candidates for hiring.

Establishes performance standards for assigned activities and reviews output to ensure standards are consistently met. Conducts performance evaluations for direct reports and assists direct reports with performance evaluation process.

Provides support, direction and coaching to assigned staff in areas of hiring, training, disciplinary action, problem resolution, planning and work assignment delegation.

Ensures compliance with all applicable local, state, and federal regulations and guidelines regarding the conduct of clinical trials (cGCP).

Ensures compliance with all Company policies and procedures including safety rules and regulations.

Establishes deadlines for conducting assigned tasks and assists in formulating an overall timetable for conducting clinical trials. Monitors progress of assigned tasks and initiates corrective action to meet agreed upon deadlines.

Contributes to development, review and approval of protocols and reports for clinical studies.

Reviews and approves Statistical Analysis Plan for clinical studies and Statistical Report for Phase III studies.

Contributes to FDA pre-meeting documentation and submissions. Attends meetings, if required.

Reviews and approves final statistical documentation files and electronic files for submission to FDA.

Develops and executes plan for installing and validating new and upgraded software.

Evaluates outcomes of independent audits of Study Reports and agrees on corrective action.

Performs related duties as assigned.

Knowledge of

Current clinical research procedures and practices.

Principles and practices of therapeutics, pharmacokinetics and biostatistics.

Basic project planning, resource estimation and project tracking procedures.

Federal regulations and guidance concerning the conduct of clinical research including Good Clinical Practice (GCP)

Business scientific and personal computer software applications.

Principles and practices of budget preparation and administration.

Administration, supervision and training practices and methods.

Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.

Current Company policies, practices and procedures, including safety rules and regulations.

Statistical principles and methods specifically in the area of clinical research.

Statistical programming including detailed working knowledge of SAS.

Database structures and data handling procedures.

Regulatory requirements relating to the conduct and reporting of statistical analyses.

Skill In:

Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.

Interacting and negotiating effectively with others.

Preparing, presenting and administering budgets and financial reports.

Communicating clearly and concisely, both orally and in writing.

Managing multiple projects, duties and assignments.

Interpreting and applying Federal, state and local policies, procedures, laws and regulations.

Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.

Establishing and maintaining cooperative working relationships with others.

Bachelors degree in a scientific/technical or related field from an accredited college or university, and seven (7) years pharmaceutical/clinical experience, including two (2) years in a supervisory or management capacity, or an equivalent combination of education and experience.

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