Biostatistics & Statistical Programming, Process and Training Director

Responsible for leading continued Process & Standard Operating Procedure (SOP) improvement, Training, Quality Indicator review and reporting and Initiative Management from a Business Operational perspective, with a focus on Biostatistics & Statistical Programming. Responsible for enabling Parexel to deliver clinical research projects efficiently and consistently, achieved by developing and maintaining fit for purpose oversight and operating standards and training programs in collaboration with other functions and SBUs.

Departmental Leadership Proactively lead, manage, and successfully deliver key cross-functional initiatives within Biostatistics & Statistical Programming, GDO or Parexel as opportunities arise. Team Leadership Lead (virtual) team(s) to ensure delivery of high-quality output by monitoring performance. Train and mentor team(s) according to job role expectations. Meet with full team(s) on a regular basis with comprehensive communication and guidance. Promptly deliver positive and constructive feedback to team members and assist team members’ manager with formal staff review processes e.g. performance reviews to corporate standards and timescales. Quality Management & Compliance Lead Parexel process document authoring and reviewing to improve efficiencies and profitability. Lead Functional process training and mentoring program to improve efficiencies and competency. Lead reviews of role specific training curricula. Maintain a knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements and Parexel processes. Maintain a knowledge of Industry trends and future developments in process and technology. Initiatives Lead and contribute to initiatives that require cross functional collaborations. Lead and/or participate in Parexel and department system/standards improvement activities. General Activities Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. Complete routine administrative tasks promptly (e.g. timesheets, metrics, travel expense claims) QualificationsThe position at Parexel requires a diverse skill set across three main categories: Leadership, Personnel Management, and Business Operations.

Leadership Skills: Strong ability to build and lead virtual teams independently and with authority. Outstanding negotiation and organizational skills. Excellent analytical and problem-solving skills. Excellent communication skills with a diplomatic approach including the ability to work with various personalities and perspectives. Excellent ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail. Effective time management to meet objectives. Demonstrated proactive thought process to minimize and mitigate risk independently. Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development. Ability to make appropriate decisions in ambiguous situations. Personnel Skills: Excellent interpersonal, oral, and written communication skills. Strong ability to gain trust and confidence with a variety of clients as well as within Parexel. Excellent learning ability and flexibility. Excellent managerial courage, resilience, and ability to adjust to a rapidly changing environment. Excellent presentation skills: internal, external, and to large audiences (including experience or willingness to take part in conference presentations) Work with integrity. Competent in written and oral English and local language (as applicable) Ability to travel as required. Business Operations Skills: Comprehensive knowledge of relevant software. Excellent commitment to Quality. Understanding of GDO tasks, specifically within Biostatistics & Statistical Programming, regulatory requirements, and data standards. Ability to identify any bottlenecks during operational processes and bring to the attention of the senior management team at Parexel while, in tandem, providing the client with potential solutions. Lead and guide clients to finalize Key Performance Indicators (KPIs)/metrics. Maintain maximum utilization of self and team Drive functional compliance to SOPs.

Knowledge and Experience: Significant work experience in similar position. Acted in a leadership role in their area of expertise. Proven record of leading project and program teams, with proven team success. Excellent understanding of cross functional activities. Demonstrated and comprehensive patient and customer service focus. Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures.

Education: Bachelor’s degree preferably in a science or industry-related discipline or equivalent experience. Master’s degree preferably in a science or industry-related discipline or equivalent experience. Certification or involvement in a professional society or organization is recommended.