He/She will have overall responsibility for customers management and operational excellence of the Data Management and Statistics department. This includes building and leading the Data Management and Statistics department team, establishing, and maintaining departmental procedures, as well as supervising the selection, management, and oversight of external third parties. He/She will provides solid expertise on biostatistics, data management, and statistical programming activities within the Company and ensures related services meet and exceed established standards. Finally, the Director, Biometrics engages in structures and process improvement initiatives and facilitates communication and translation of business, regulatory and technical or scientific requirements among intra- and inter-departmental Teams.
Main Duties & Responsibilities
Manages customer accounts
Provides input to proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules, standards and budgets
Provides insight and expertise on all aspects of Data Management and Statistics and in collaboration with key managerial roles within the department (e.g., Head of Clinical Data Management Processes, the Associate Director, Statistical Programming, the Associate Director, Biostatistics and Analytics and the Associate Director, Clinical Data Management)
Provides direction in carrying out project assignments, interfacing with clients and other internal departments to accommodate project specifications and targets, while prioritizing deliverables and milestones for multiple clinical trials and identifying potential areas of risk
Manages resources for all projects and across all intradepartmental disciplines to actualize department and Company objectives and goals. Escalates resources issues to Top Management
Oversees all departmental activities and ensures compliance with internal and external standards, e.g., the Company's Integrated Management System (IMS)
Such Activities Include But Are Not Limited To
the development, improvement, and adaptation of standards for data management, programming and biostatistics activities
the development and maintenance of programs, templates, macros, etc.
the provision of expertise and advise to other disciplines within the Company by Data Management and Statistics employees (e.g., input provided in the context of Case Report Forms development, databases design, Data Management Plans development, data cleaning and query resolution, data transfers, safety database reconciliation, coding process, database freeze and lock, etc.)
the development of Statistical Analysis Plans, tables, figures, listings. Data Review and Dissemination Plans
the development, review and approval of scientific abstracts, posters, and manuscripts
Leads strategic decision-making and develops solutions for Data Management and Statistics issues that may arise in the context of ongoing clinical trials. Approves related departmental corrections and corrective actions
Actively participate in data management and statistics vendors evaluation, selection, and management including monitoring
Represents the Data Management and Statistics Department in cross-functional and designated external meetings
Leads system and process improvement efforts and approved identified improvements brought to his attention by relevant responsible roles within the department
Provides consultancy, mentors and proactively manages and develops the performance of Data Management and Statistics employees. Collaborates with direct reports and other key managerial roles within the department, to ensure all employees are properly trained and qualified to meet the needs of the business
Develops and oversees monitoring of departmental objectives and Key Performance Indicators (KPIs)
Maintains up-to-date knowledge and competencies within relevant therapeutic, scientific, technical and regulatory guidelines and requirements
Ensures all departmental controlled documents, including SOPs, WPDs, etc., are up-to-date and in compliance with applicable regulatory and other requirements
Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection
Education Requirements
Required: MSc in Statistics, Biostatistics, Mathematics, Epidemiology, Data Science, Data Analysis or other applied sciences relevant field
Desirable: PhD in one of the above fields
Professional Experience Requirements
Required
Minimum 10 years experience in a CRO, a pharmaceutical or equivalent organization in a relevant field such as Biostatistics, Data Management Programming
Minimum 5 years experience in people management and leading a team
Experience in building the data infrastructure and processes to meet regulatory requirements in filling (IND, NDA, BLA etc.)
Deep understanding and demonstrated experience of the programming pipeline (SAS, R and other relevant software) in the pharmaceutical industry
Experience in using Medidata RAVE
Proficient knowledge of industry standards (CDSIC, SDTM and ADaM), medical terminology, safety data and coding dictionaries (MedDRA and WHODD) terminology used in the analysis and submission of clinical data
In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Regulatory (FDA and EMA) submission experience, creating programming files required to support and electronic submission in eCTD format
Hands-on experience in supporting clinical studies, working with clinical team
Experience in leading early and late-phase clinical studies regulatory guidance, industry standards, statistical terminology used in the analysis and submission of clinical data and interacting with regulatory agencies on data management-related issue/topics
Desirable
Successful and demonstrable track record delivering end-to-end (from conception to benefits realization) process improvement initiatives
Knowledge of programming languages in addition to SAS such as R and Python, and programming tools used in clinical research and drug development
Language Skills Required
Excellent command of spoken and written English
Key competencies
Effective Presentation Skills
Excellent project management skills
Strong Interpersonal And Communication Skills
Ability to work in a fast-paced and deadline-driven environment
Strong attention to detail and commitment to quality
Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Superior leadership skills and the ability to mentor and motivate staff
Positive attitude and the ability to collaborate well with others
Capability of delegating tasks and facilitating the completion of assignments at driving innovation in developing new ideas related to process improvements
