Director, Biostatistics

Pharpoint Research, Inc.; Durham (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

PharPoint Research, Inc. seeks an experienced leader to oversee Biostatistics and Statistical Programming, ensuring timely, accurate project execution and compliance with GCP and SOPs.

You will partner with the Executive Director/CSO to plan resources and recruit top talent across multiple studies. Candidates should have a Master’s degree in Statistics or related field, at least 10 years in clinical research, and 8 years of supervisory experience, with demonstrated ability to manage budgets and

Qualifications

• Master’s degree in Statistics, Computer Science, or related field.
• 10 years of related clinical research experience; 8 years leading statistical or programming activities.
• 8 years of supervisory experience required.
• Knowledge of drug development process and FDA/ICH guidelines; experience with regulatory submissions.
• Knowledge of statistical software packages used to conduct analyses.
• Able to manage many projects and priorities; strong motivation and team leadership.

Responsibilities

• Provide administrative oversight for Biostatistics and Statistical Programming functions.
• Develop data-driven resource plans and recruit high-caliber candidates.
• Ensure compliance with GCP and PharPoint SOPs and manage project budgets.
• Lead and motivate departmental staff, coordinate with client and regulatory teams.
• Establish strong working relationships with clients, vendors, and regulatory agencies.

Skills

Drug development knowledge

Regulatory submissions

Statistical software

Clinical research process

Education

Master’s degree in Statistics or related field

Job description

Description

BASIC SUMMARY

Provide administrative and functional oversight for the biostatistics and statistical programming (BioSP) functions of the organization. Works with Executive Director and/or Chief Scientific Officer to develop detailed data-driven resource plans and spearhead the recruitment of high caliber candidates. Oversee the efficient, accurate, and timely execution of all assigned projects within BioSP. Engages with sub-functions within BioSP to ensure the company goals and visions are maintained and promoted. Ensure compliance of the 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

• Continuously enhances the data and analytics capabilities of Biostatistics and Statistical Programming.
• Direct activities of assigned group(s) to ensure effective performance of function.
• Serve as a model to departmental subordinates as it relates to effective time management, communication, and utilization of resources.
• 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.
• Ensure optimum performance of group function. Consider and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of the-art practices.
• Provide leadership and motivation to departmental personnel.
• Engage collaboratively and cooperatively with other departmental and company staff to ensure that project and department activities are successfully completed.
• Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel.
• Assist in the marketing and proposal development activities of the department.
• Actively monitor project budgets and help staff identify resourcing or scope of work changes.
• 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.
• 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.
• Assist in the development, maintenance, and communication of departmental systems and SOPs. Partner with Human Resources to develop and approve job descriptions for subordinate positions; ensure communication of duties and responsibilities to employees.
• 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.
• Monitor and provide daily supervision and review work of assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
• 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.
• Ensure the efficiency, quality, and integrity of data reporting, project and supervisory activities executed.
• Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
• Perform all other related duties as assigned.

Requirements

QUALIFICATIONS

• Education: Master’s degree (M.A., M.S.) or equivalent in Statistics, Computer Science, or related field.
• Experience: 10 years related clinical research experience; 8 years successfully leading statistical or programming activities in clinical research. 8 years supervisory experience required.
• Certification/Licensure: None
• Other: Knowledge of the drug development process and FDA and ICH Guidelines required. Experience with regulatory submissions is required. Knowledge of one or more statistical software packages used to conduct statistical analyses required. Demonstrated knowledge of the clinical research process, different operating systems and platforms, and team organizational skills 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.
• 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.