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Principal Biostatistician

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POST DATE 8/24/2016
END DATE 10/15/2016

Chiltern Wilmington, NC

Job Classification
Full Time
Company Ref #
Wilmington, NC
Entry Level (0 - 2 years)
Job Type
Masters Degree
AJE Ref #






Plan, analyze and summarize the results of individual clinical studies or groups of studies (integrated summaries) and coordinate the development and review of regulatory submissions (e.g., NDAs). Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines. Manage and/or mentor junior level biostatistics staff.



Biostatistical Activities:

* Apply knowledge of basic and complex statistical design, analysis, and programming techniques

* Efficiently and effectively coordinate statistical activities for multiple projects simultaneously

* Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies

* Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations

* Develop and execute study designs and regulatory strategy as related to drug development

* Maintain a professional working relationship with sponsors, collaborating associates, and vendors

* Represent department and company in a multi-disciplinary setting, including project team meetings and client meetings/presentations

* Effective oral and written communication of statistical concepts and results

* Assist in the development and review of statistical analysis plans based on study specific documents and sound statistical methodology

* Assist in developing, maintaining, and producing statistical programs and specifications used in creating analysis datasets, tables, listings, and figures

* Ensure the quality and integrity of data analysis and reporting

* Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate

* Actively monitor project budgets and help staff identify resource or scope of work changes

* Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management

* Attend related continuing education programs, professional meetings, and other career development activities sponsored

* Perform all other related duties as assigned

Performance and Quality:

* Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements

* Ensure timely completion and documentation of all training requirements

* Ensure study responsibilities for the biostatistics and statistical programming team are completed within timelines and under budget

* Actively contribute to the success of relevant project activities and administrative/departmental initiatives

General Duties:

* Manage and/or mentor junior level biostatistics staff as appropriate; provide direct supervision and review work of limited assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures

* Serve as a model to departmental staff as related to effective time management, communication, and utilization of resources. Provide leadership and motivation to departmental personnel including staff who are not direct reports

* Assist in the marketing of the department and company

* Assist in bids and proposal development activities for the department

* Identify training and development needs of direct reports; ensure that direct reports receive departmental orientation and necessary on-the-job training, as appropriate

* Monitor performance of direct reports and assist in providing regular coaching and counseling. Assist in preparation and delivery of performance reviews of direct reports, as appropriate

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

* Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel

* To maintain awareness of current development in the therapeutic areas relevant to his/her project(s), by reading scientific and medical literature

* At all times to promote the image of Chiltern, acting as an ambassador to the Company

* To undertake non-project related tasks as appropriate as assigned by the Manager

* To ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)

* Define achievable goals and tasks as related to a departmental objective or initiative. Identify areas for improvement (e.g. SOPs, processes etc)

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

* Perform all other related duties as assigned



* Master s degree, equivalent, or higher in Biostatistics or related field

* Extensive experience in statistical design and analysis methodology or basic and complex studies

* Extensive experience in leading statistical activities in clinical research

* Experience with regulatory submissions and support preferred

* Ability to program in one or more statistical software packages (SAS preferred) used to conduct statistical analyses

* Excellent verbal and written communication

* Proven ability to effectively communicate statistical concepts


* Previous experience in a pharmaceutical research or CRO setting required

* Some supervisory experience preferred

* Exhibited a positive attitude and willingness to learn and lead in a team setting

* A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.


on application


Full Time


Email Timica Lindsey
+1 919 468 2282