Director Biostatistics

Full Time Durham, NC or Wilmington, NC OfficeBASIC SUMMARY:Provide technical, administrative, and functional oversight for the biostatistics sub-functions of the Biostatistics and Statistical Programming (BioSP) department which include statistical consulting, statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Oversee the efficient, accurate, and timely execution of all assigned biostatistics projects within BioSP. Ensure compliance of the biostatistics sub-function 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:Develops and implements a strategic plan for the biostatistics sub-function that aligns with the vision and goals of the department. Assist in the development of short- and long- range operating objectives, budget, organizational structure, and staffing requirements. Assist in the development of a departmental plan for backup and succession of key departmental personnel.Aligns business development opportunities with the strategic plan, including serving as proposal design lead, technical writer and/or review, as necessary.Determines staffing needs of the biostatistics sub-function and systems for biostatistical research and reporting. Actively monitor project budgets and help staff identify resourcing or scope of work changes.Works with directors of other sub-functions within the department and company to assure that biostatistics services meet the company’s needs.Reviews scientific proposals, study protocols, papers, and final study reports to assure the appropriate use of statistical and reporting procedures and interpretation.Influences proper use of statistics and adherence to reporting standards across a comprehensive research portfolio.Works with biostatisticians and programmers to ensure the quality and timeliness of deliverables.Oversees the work of the biostatistics staff in the design and implementation of analysis plans for research studies to assure that sound analytical procedures are efficiently applied.Represents the department on committees, cross-functional meetings, and audits. Interact collaboratively and cooperatively with other departmental and company staff to ensure that project and department activities are successfully completed.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.Evaluates current statistical methodologies and regulatory guidance to promote continual innovation in statistical design and compliance with regulatory expectations.Serve as a model to departmental subordinates as it relates to effective time management, communication, and utilization of resources.Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Serve as primary statistical oversight for Biostatistics standalone or otherwise complex studies.Develop and review statistical documents including protocols, statistical analysis plans, analyses and study reports based on study specific documents and sound statistical methodology.Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.Provide accurate and timely status updates to other team members, colleagues, and senior management.Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, and client meetings/presentations.Ensure optimum performance of group function. Propose and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of the-art practices.Assist in the development, maintenance, and communication of departmental systems and SOPs.Interview and select qualified departmental personnel. Recommend personnel actions, including hiring, promotions, and raises. Prepare and deliver performance evaluations of direct reports. Partner with Human Resources in the handling of disciplinary issues. Prepare appropriate personnel action paperwork. Partner with Human Resources to develop and approve job descriptions for subordinate positions; ensure communication of duties and responsibilities to employees.Monitor and provide daily supervision and review work of assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures. Provide effective leadership and motivation to departmental personnel.Identify training and development needs of direct reports. Assist in the development, implementation, and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training.Perform all other related duties as assigned.QUALIFICATIONS:Education: Master’s degree (M.A., M.S.) or equivalent in Biostatistics or related field.Experience: 10 years successfully leading statistical activities in clinical research. 8 years supervisory experience required.Certification/Licensure: NoneOther: Knowledge of the drug development process and FDA and ICH Guidelines required. Experience with regulatory submissions is required. Knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research required. Effective oral and written communication of statistical concepts and results required. 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 and ensure productivity and smooth operation in conditions with ambiguity. Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership. Strong people manager with track record of staff development. 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 requires occasional domestic/international travel.Must have a valid driver’s license with no limitations on driving availability.