Principal Statistical Programmer in Durham, North Carolina at PHARPOINT RESEARCH INC

BASIC SUMMARY:

Provide overall technical, administrative and functional oversight for the programming activities supporting biostatistics which include the development of analysis datasets, and statistical summaries. Oversee the efficient, accurate, and timely execution of all programming activities within biostatistics. Ensure compliance of the programming group in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by PharPoint Research, Inc. and its sponsor clients.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Efficiently and effectively coordinate statistical programming activities for at least 4 projects simultaneously which could be satisfied by 4 separate protocols, a program consisting of at least 2 separate compounds with multiple studies per compound, or NDA submission.
• Plan and coordinate processes to ensure quality and efficient programming, verification, and documentation of programs for use in creating clinical databases, analysis datasets, tables, listings, and figures.
• Provide senior level oversight for departmental teams.
• Ensure the efficiency, quality, and integrity of analyses, data reporting, project, and supervisory activities executed.
• Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, regulatory agencies, collaborating associates, vendor personnel and subcontract personnel.
• 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.
• Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams.
• Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
• Efficiently manage project budgets to identify resourcing or scope of work changes.
• Provide accurate and timely project status updates to other team members, colleagues, and senior management.
• 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.
• Contribute to ongoing improvement of programming processes and methodology.
• Provide senior leadership and guidance to departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
• Manage activities of assigned project team(s) to ensure effective performance of a clinical trial program. Provide direction to team members working toward a common goal and successfully coordinate multiple priorities.
• Interact collaboratively with staff across departments to ensure that project and departmental activities are successfully completed.
• May participate in the interview and selection of qualified personnel.
• Assist in the development, implementation, and delivery of departmental training programs; server as a mentor to junior level programmers.
• May attend related continuing education programs, professional meetings, and/or company career development activities sponsored or approved by the company.
• Assist in the development, maintenance, and communication of departmental systems and SOPs.
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in Statistics, Computer Science or related field.
• Experience: 9 years relevant experience in clinical research. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None
• Other: Effective team player: willingness to go the extra distance to get results, meet deadlines, etc. Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change. Strong ability to motivate staff within project teams and ensure productivity and smooth operation in conditions with ambiguity. Leadership skills in priority evaluations, adapting to changes, conflicts resolutions, and effective partnership. Knowledge of one or more statistical software packages used to conduct statistical analyses required. Ability to read, write, speak, and understand English required.

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.

COMMENTS:

• This position may require occasional domestic/international travel.
• Must have a valid driver’s license with no limitations on driving availability.