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Associate Director, Biostatistics

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

Chiltern Wilmington, NC

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






Provide daily supervision of Biostatistics operations and personnel. Ensure departmental goals and deliverables are met. 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

* Develop and review 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, focusing on expansion of future business

* Participate 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 provide regular coaching and counseling. Assist in preparation and delivery of performance reviews of direct reports, as appropriate

* Oversee the interview and selection of qualified personnel

* Develop, implement, and deliver departmental training programs

* Assist in the development of short and long-range operating objectives, organizational structure, and staffing requirements

* 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

* 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


* Significant previous experience in a pharmaceutical research or CRO setting required

* Significant supervisory experience required

* 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