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Senior Biostatistician

Company: PharPoint Research Inc
Location: Durham
Posted on: September 13, 2020

Job Description:

Develop and implement statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Participate in the project specific programming of statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by PharPoint Research, Inc. and its sponsor clients. May be responsible for administrative supervision of interns.

Position Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES:

Coordinate statistical reporting activities for multiple projects simultaneously.

Develop and review statistical analysis plans based on study specific documents and sound statistical methodology.

Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.

Ensure the efficiency, quality, and integrity of data reporting, project and supervisory activities executed.

Actively monitor project budgets and help staff identify resourcing or scope of work changes.

Provide accurate and timely status updates to other team members, colleagues, and senior management.

Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, and client meetings/presentations. Maintain a positive working relationship with clients.

Interact collaboratively with other departmental staff to ensure that project and department activities are successfully completed.

Advocate the departmental team approach for effective management of broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations.

Assist in the interview and selection of qualified personnel.

Assist in the development, implementation, and delivery of departmental training programs.

Assist in providing regular coaching and counseling.

Assist in the development, maintenance, and communication of departmental systems and SOPs.

May provide direct daily supervision of limited assigned departmental employees. If applicable, review work of direct reports to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures; identify training and development needs of direct reports; ensure that any direct reports receive departmental orientation and necessary on-the-job training; assist in preparation and delivery of performance reviews of direct reports.

Perform all other related duties as assigned.

QUALIFICATIONS:

Education: Master’s degree (M.A./M.S.) or equivalent in Biostatistics or related field

Experience: 3 years related clinical research experience.

Certification/Licensure: None.

Other: Knowledge of the drug development process and FDA and ICH Guidelines required. Knowledge of basic statistical design, analysis, and programming techniques utilized in clinical research required. Effective oral and written communication of statistical concepts and results required. Knowledge of one or more statistical software packages used to conduct statistical analyses required. Ability to read, write, speak, and understand English required.

This position requires occasional domestic/international travel.

This position requires a valid driver’s license and the ability to operate a motor vehicle.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is regularly required to talk, hear and type at a computer.

Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT:

General office working conditions, the noise level in the work environment is usually quiet.

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. This position is currently accepting applications.

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Keywords: PharPoint Research Inc, Durham , Senior Biostatistician, Other , Durham, North Carolina

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