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Principal Statistical Programmer

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POST DATE 9/15/2016
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)
Bachelors Degree






Provide lead statistical programming support in the project specific programming of 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 statistical programming staff.

This position can be home-based or office-based.



Statistical Programming Activities:

* Coordinate programming activities for several clinical research projects

* Demonstrated ability to work efficiently and produce quality results under time constraints

* Serve as the statistical programming lead on internal project teams and coordinates programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures

* Facilitate advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department

* Work independently to carry out assignments with little direct supervision

* Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams

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

* Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, collaborating associates, and vendor personnel

* Lead and organize project programming teams, typically for multiple protocol or otherwise complex projects

* Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams

* Communicate accurate and timely status updates to other project team members and department management

* Actively manage programming activities within parameters of project budgets

* Contribute to ongoing improvement of programming processes and methodology

* 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 of scope of work changes

* Perform other 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 statistical programming 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 subordinates as it relates to effective time management, communication, and utilization of resources. Provide leadership and motivation to departmental personnel

* 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

* Assist in ensuring the optimum performance of group function. May recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices

* Assist in the interview and selection of qualified personnel

* To liaise with other members of the Chiltern project team and clients effectively

* 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.)

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

* Perform all other related duties as assigned



* Undergraduate degree or higher in Biostatistics, Computer Science, or related field

* Extensive experience leading statistical programming activities in clinical research (Candidates should have many (e.g., 7+) years of relevant direct experience in CRO/pharma clinical trials in Biometrics as a Statistical Programmer.

* Extensive knowledge of one or more statistical software packages (SAS preferred) used to conduct statistical analyses (Individuals should have at least some CDISC experience (high-level preferred), proven study leadership skills, proficiency in SAS, ability to independently produce a wide range of complex datasets, tables and listings (experience with figures is a plus), efficacy experience and solid industry knowledge and a desire to contribute in the role of Lead Programmer on one or more studies.)

* Excellent verbal and written communication


* Previous experience in a pharmaceutical research or CRO setting required

* Some supervisory experience preferred

* Exhibit 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.


on application


Full Time


Email Timica Lindsey
+1 919 468 2282