Subject Matter Expert (SME), Biostatistics

PharPoint Research, Inc.; Durham (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

A consulting firm in statistical services seeks a subject matter expert for strategic consulting roles. The role includes setting development strategies, reviewing study protocols, and fostering relationships with clients and regulatory agencies. Candidates should possess a terminal degree related to statistics and have extensive experience in clinical research, particularly in consulting. Effective communication, innovative problem-solving skills, and knowledge of regulatory submissions are essential. This position requires travel and client-facing responsibilities.

Qualifications

• 15 years of clinical research experience, with at least 10 years in consulting.
• Broad understanding of statistical principles and clinical trial methodology.
• Effective communicator with the ability to explain complex concepts.

Responsibilities

• Provide strategic consulting on product development strategy.
• Evaluate industry guidance for statistical best practices.
• Review scientific proposals and study reports for compliance.
• Attend industry meetings and represent the company.
• Develop strategic alliances to enhance service offerings.
• Operationalize consulting opportunities with business development.
• Lead multi-disciplinary project teams and client meetings.
• Drive NDA submissions and complex multi-protocol programs.
• Develop strategic alliances to expand services and value.
• Ensure data reporting quality and timely delivery.

Skills

Strategic consulting

Statistical methodology

Communication

Time management

Teamwork

Education

Terminal degree in statistics or biostatistics

Job description

BASIC SUMMARY

Subject matter expert for the company’s statistical services providing statistical guidance for internal and external clients which include setting strategy for complex protocols, regulatory submissions, or development programs. Establish working relationships with internal and external clients and foster new business. Establish solid strategic partnerships to enhance PharPoint Research’s (PharPoint) service offerings. Partner with business development and operations to ensure a strong strategic approach to each business opportunity. Maintain billable requirement through external consulting opportunities or through internal support opportunities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Successfully provide strategic consulting to clients on their product development strategy, including development options, statistical study design, specification of endpoints, and sample size determination/justification.
• Continually evaluates and stays abreast of industry guidance to ensure that PharPoint’s Biostatistics and Statistical Programming (BioSP) department is adopting best in practice methodology.
• 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.
• Represents the Company by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals.
• Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel.
• Successfully operationalize consulting opportunities for the organization in conjunction with business development or other departmental personnel.
• Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, client meetings/presentations, and meetings with regulatory agencies.
• Advocate the corporate team approach for effective management of broad-based projects such as NDA submissions, clinical development programs, or complex, multi-protocol programs potentially coordinating activities across multiple locations.
• Under the direction of the executive team, identify and develop strategic alliances/partnerships, that provide synergy, new business networking, and create a competitive advantage to PharPoint and provide value to clients.
• Monitor and manage success of strategic alliances through the establishment of key performance indicators.
• Implement and integrate new service offerings as assigned.
• Successfully serve as a model to department subordinates as it relates to effective time management, communication, and utilization of resources.
• Interact collaboratively and cooperatively with other departmental and company staff to ensure that project and department activities are successfully completed.
• Participate with business development personnel to develop and provide technical presentations to prospective clients.
• Assist in the marketing and proposal development activities of the department and/or functional area of expertise.
• Successfully serve as business portfolio director for selected list of clients.
• 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.
• 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.
• Monitor and provide daily supervision and review work of assigned employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
• Ensure the timeliness, efficiency, quality, and integrity of data reporting, project and supervisory activities executed.
• Perform all other related duties as assigned.

QUALIFICATIONS

• Education: Terminal degree related to statistics or biostatistics or relevant work experience.
• Experience: 15 years related clinical research experience with at least 10 years in a consulting capacity.
• Certification/Licensure: None.
• Other: Broad and thorough understanding of statistical principles and clinical trial methodology including FDA and ICH guidance and ability to practice and implement the same. Able to develop innovative/creative statistical/technical solutions to complex problems. Experience with regulatory submissions is required. Broad knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas. Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc. 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 at least 50% of hours to be directly billable to clients.
• This position requires occasional domestic/international travel.
• Must have a valid driver’s license with no limitations on driving availability.