About Us Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Approach * We bring the customer and the patient to the center of everything that we do. * We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Why Work at Syneos Health? * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong. Job Responsibilities Serves as a Statistical Department Resource 1. Mentors biostatisticians on job skills and oversees or develops training plans or materials for Biostatistics associates. 2. Conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel. Directs Activities of Other Biostatistics Personnel 1. DIRECTS THE ACTIVITIES OF OTHER BIOSTATISTICS PERSONNEL ON ASSIGNED PROJECTS TO ENSURE TIMELY COMPLETION OF HIGH-QUALITY WORK. 2. PROVIDES INDEPENDENT REVIEW OF PROJECT WORK PRODUCED BY OTHER BIOSTATICIANS IN THE DEPARTMENT. Provides Support Across All Statistical Tasks * Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. * Collaborates with sponsor, if required. May be Responsible as Lead Biostatistician * The statistical aspects of the protocol. * Generation of randomization schedule. * Input to the clinical study report. Create or Reviews Programming Specifications * For analysis datasets, tables, listings, and figures. Reviews SAS Annotated Case Report Forms * Database design. * Other study documentation. Implements Company Objectives * Creates alternative solutions to address business and operational challenges. Biostatistics Representative on Project Teams * Interfaces with other departmental project team representatives. Conducts and Participates in Verification and Quality Control * Ensures that output meets the expected results and is consistent with analysis described in the SAP and specifications. May Lead Complex or Multiple Projects * Attends regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Manages Scheduling and Time Constraints * Across multiple projects. * Sets goals based on priorities from management. * Discusses time estimates for completion of study-related activities with biostatistics management. * Adapts to timeline or priority changes by reorganizing daily workload. * Proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors Progress on Study Activities * Against agreed-upon milestones. * Ensures the study timelines for project deliverables are met. * Identifies out-of-scope tasks and escalates to management. Provides Statistical Programming Support * As needed. Participate in Data Safety Monitoring Board and/or Data Monitoring Committee Activities * Charter development. * Serving as an independent non-voting biostatistician. * Serving as a voting statistician. Maintains Well-Organized, Complete, and Up-to-Date Project Documentation * Verification/quality control documents and programs. Displays Willingness to Work with Others * Assists with projects and initiatives as necessary to meet the needs of the business. Supports Business Development Activities * Contributing to proposals. * Budgets. * Attending sponsor bid defense meetings. Performs Other Work-Related Duties * As assigned. Minimal travel may be required. Qualifications What We're Looking For * Integrated Analysis specific role. * Prior experience with the following: