PharPoint Research, Inc., is a highly reputable clinical contract research organization (CRO) seeking talented Biostatisticians at all levels to join our team. Our Biostatisticians are vital to the success of the organization and serve as statistical subject matter experts in analyzing the results of clinical trials and summarizing results. Successful candidates will 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 (SOP’s) set forth by PharPoint Research and its sponsor clients.
Applies knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research.
Maintains a professional working relationship with sponsors, collaborating associate, and vendor personnel.
Successfully represents Biostatistics section and company in a multi-disciplinary setting, such as project teams, project meetings, client meetings/presentations.
Effective oral and written communication of statistical concepts and results.
Develops and reviews statistical analysis plans based on study specific documents and sound statistical methodology.
Develops, maintains, and produces statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
Ensures the efficiency, quality, and integrity of data reporting and project activities executed.
Maintains awareness of project budgets and tasks, and effectively communicates the status of such tasks to administrative and project management.
Interacts with internal project team and supervisor to identify project priorities and communicate such activities and associated timelines to section management.
Understands and complies with all company policies and standard operating procedures.
Attends related continuing education programs, professional meetings, and the Company career development activities sponsored by or approved by Company.
Senior level Biostatisticians may also:
Serve to mentor and train newer team members and be actively involved in talent acquisition and development.
Develop and implement statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions.
Actively monitor project budgets and help staff identify resourcing or scope of work changes.
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.
Master's degree (M.A./M.S.) or equivalent in Biostatistics, Statistics, or related field, with 2 years of related work experience in a CRO or clinical research environment; or, PhD.
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.
Individuals who are passionate about their work and improving world health.
Additional Salary Information: Competitive pay and benefits, PTO, and 401k. Flexible work schedules and some telecommuting opportunities. Salary dependent on experience.
About PharPoint Research, Inc.
PharPoint Research, Inc. is a niche pharmaceutical development service provider specializing in project management, clinical monitoring, data management and biostatistics. Our staff includes some of the most talented in the industry and understands the importance of responsiveness and timely deliverables with exceptional quality. We pride ourselves on our years of experience, superb repeat client rate and the ability to consistently exceed client expectations. Founded in 2006, PharPoint has offices in Durham, NC near Research Triangle Park and Wilmington, NC.