Worldwide Clinical Trials

Role Description Independently manages statistical project support and provides expert statistical consultancy across the stats function. - Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are met by expert and timely statistical consultancy and support. - Provides expert review of study designs, analysis plans, and reports. - Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology, and writing statistical analysis plans. - Consult with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements. - Provide project support to the statistics reporting process through the specification/review of tables, figures, and listings shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations. - Undertake the preparation of final reports, including the production of tables, listings, and figures, and report writing. - Develop, evaluate, and run Statistical Analysis System (SAS) programs for the statistical analysis and reporting of clinical study data. - Ensure the maintenance of documentation, e.g., the description of programs and validation. - Produce ad hoc data summaries when requested during a trial. - Extract information from the system during a trial, e.g., summaries, data listings, study data sets. - Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation. - Make statistical contributions to manuscripts for publication/presentation. - Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings. - Lead the identification of system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting. - Support the development of statistical design and analysis policies. - Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents. - Assist with Quality Assurance and Audit requirements. - Assist the Director of Biostatistics with all other aspects of the job as required. - Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant ICH standards, and specifically with FDA Quality System Regulation (including 21CFR Part 11). - Perform other duties as assigned. Qualifications - Computer literate and numerate with a proven ability to adapt to various computer systems. - Expert-level project statistician experienced in providing statistical leadership to projects. - Design and analysis consultancy skills and knowledge across a broad range of applications. - Key competencies in customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change. Requirements - Master's level in mathematics, statistics, or another subject required with a strong statistical component. - Minimum 3 years of statistical experience leading clinical trial projects and data analysis. Benefits - Competitive benefits package depending on location. - Salary range for this position is $87,500.00 - $173,500.00 annually. - Compensation will fall within the provided range based on relevant experience, performance, education, and internal equity. - Pay equity and transparency compliance with all applicable labor laws.

• Overall coordination and management of clinical trials from start-up through closeout activities • Directs the technical, financial and operational aspects of the projects • Works with major functional area leads to identify and evaluate fundamental issues on the project • Works to ensure that all project deliverables meet the customer’s time/quality/cost expectations

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects • Typically involved in all stages of the clinical study • Conduct study initiation visits (SIVs) • Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects • Conduct study initiation visits (SIVs) • Compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects • Conduct study initiation visits (SIVs) • Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements • Perform various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets • Train the sites to collect data properly and report any potential safety-related events • Manage the site's activities during study maintenance and close down research activities at the sites once the study has concluded

• Engage with senior management to establish strategic departmental initiatives and objectives • Accountable for clinical team key performance indicators (KPIs) and associated metrics • Drive identification of process improvement needs and coordinate initiatives to support these activities • Lead new quality management document (QMD) developments, including authoring and reviewing QMD and guidance documents • Create and lead CAT committees to further initiatives • Actively participate in the identification and development of new service arms • Actively participate in the improvement of existing service arms • Drive business development activities for CAT, including proposal input, participation in capabilities presentations, and bid defense activities • Participate in internal and external marketing activities • Serve as an external spokesperson for CAT • Provide oversight, training, and support for the clinical team • Actively engage in the protocol development process, including research, literature review, assessment review, and risk assessment • Identify clinical needs for upcoming and current projects, and track and review them with CAT Clinical Staff and Leadership • Resource CAT study projects as Resource Manager • Accountable for all contracted clinical activities in clinical trials • Provide clinical expertise and review of clinical plans and training content for CAT-awarded trials • Oversee development of assessment training content and plans, ensuring training curriculum and materials (including videos) meet protocol, copyright holder, author, and sponsor requirements • Serve as Subject Matter Expert (SME) for CAT clinical activities, including therapeutic area and assessment advisement and guidance • Provide clinical expertise on measurement administration and scoring conventions • Support scale acquisition activities, including scale versioning • Accountable or consulted, depending on study assignment, on source document creation to ensure materials align with study protocols • Lead development of data surveillance plans and oversee execution of data surveillance throughout trials • Accountable for CAT sponsor and team reports • Manage clinical staff directly • Lead vetting, hiring, and onboarding of new clinical staff • Oversee coordination and execution of onboarding and mentoring assignments • Oversee CAT study deliverables from launch through study closeout • Ensure CAT Clinical staff operate in a constant state of inspection readiness • Contribute significantly to strategic departmental, sponsor-related, and cross-functional initiatives • Collaborate with CAT staff, Project Management, and Contracts on study budget development, including Work Orders, Letters of Intent, Change Orders, and Change Notification Forms • Drive research activities, including data analysis, white papers, posters, and related contributions • Apply advanced knowledge of industry regulations, GCP, and ICH guidelines to ensure full operational and clinical compliance during clinical trial conduct • Perform other duties as assigned

• Medically manages clinical trials to which s/he is assigned as MM • Serves as Global Lead MM (GLMM) for pan-regional and/or global trial(s) • Collaborates with the other members of the Medical & Safety project teams to process Serious Adverse Events (SAEs) • Provides therapeutic and protocol-specific training to the project teams • Contributes medical input into the design of clinical development programs

• Provide therapeutic and operational expertise throughout the program/project delivery lifecycle • Ensure that projects within the Franchise are properly resourced • Responsible for collaborating with Therapeutic team to provide effective delivery strategies and solutions for Franchise projects and programs • Act as main contact person for the Project management Franchise Lead • Present at Proposal Defense/client meetings as needed to support new or ongoing business • Ensure LCRAs are trained to support the clinical scope of work (which includes SOP review, QI/CAPA understanding, Clinical Monitoring Plan) • Coordinate and collaborate, with Worldwide Global Quality Assurance, to provide training opportunities identified in CAPA information • Coordinate efforts between the Project Management, Site Management, and Study Start Up • Establishing regular communication to include quality metric (SVR compliance, SDV metrics, on site metric discussion, etc.) and overall "health" of the projects (data query status, managing to the SOW, resource status) • Conduct appraisal performance review for direct reports

• Provide administrative and project tracking support to the clinical project team • Arrange and track system access for project team • Maintain and quality audit to assure the most recent revisions of documents are on project portals • Assist project team with preparation and shipment of clinical trial documentation • Maintain version and quality control of project documentation • Generate and distribute minutes for project related meetings • Maintain current participating site and personnel information • Assist with the interviewing, coaching, training and development of new employees • Participate in special and complex projects to continuously improve processes

• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs • Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions • Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. • Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements • Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff