Role Description A well-established, secure and commercially active biopharma is expanding its US biostatistics team. This is a hands-on study statistician role within a fully in-house function. - Serve as study statistician across oncology trials - Author and review Statistical Analysis Plans (SAPs) and statistical sections of clinical protocols - Develop and review TFLs and outputs for regulatory submissions - Conduct ad hoc statistical analysis and contribute to data review - Support regulatory interactions, including IND, NDA/BLA submissions - Collaborate cross-functionally with clinical development, data management, and programming Qualifications - PhD in Biostatistics or Statistics; Masters with supplementary experience considered - Strong oncology experience - Demonstrable experience working directly for a sponsor company - Proficiency in SAS and/or R - East Coast based only Requirements - Compensation DOE - $160,000 - $200,000 base salary + benefits

Role Description TRIO is looking for a Clinical Research Associate to join our Monitoring Resource team. Reporting to the CRA Line Manager, this position will be a remote full-time freelance position based in Ireland. - Performing data verification of source documents; - Conducting site visits, including pre-study, initiation, monitoring, and termination; - Confirming adherence to all FDA, ICH-GCP, and local regulations; - Ensuring implementation and compliance with FDA, and ICH-GCP guidelines; - Participating in budget negotiation and follow-up where applicable; - Assisting with data validation and query resolution; - Mentoring junior team members as required; - Ensuring the completion and collection of regulatory documents. Qualifications - A minimum of 2 years of monitoring experience in oncology trials; - Experience monitoring in early-phase trials will be valued; - Completion of a science-related Bachelor’s degree; - Excellent knowledge of medical terminology and clinical monitoring process; - Strong ICH-GCPs knowledge; - Experience with clinical trial information systems; - Ability to travel up to 60% on average; - Must be legally authorized to work in the country. Requirements - Prior to applying please review TRIO's Applicant Information Notice; - To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI; - To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI-generated responses during interviews or assessments. We want the opportunity to get to know you and your experience. Benefits - Teamwork; - Passion; - Integrity; - Innovation.

• Develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. • Design and develop clinical protocols and execute clinical studies with minimal supervision. • Work closely with clinical research associates, clinical trial assistants, and data management for the conduct and execution of studies. • Drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. • Provide guidance to monitors about monitoring needs, and oversee compliance work on the study. • Take a leadership role in external communication with investigators and study teams. • Complete source data verification of clinical study data entered in EDC system or on case report form.

Role Description The Clinical Specialist (CS) is responsible for integrating the company's technology into the Cardiac Cath, Hybrid OR and IR Labs of new and existing ACIST accounts. The CS installs ACIST equipment/devices, educates customers on the optimal usage and builds relationships at multiple call points to ensure long term customer satisfaction. The CS contributes to consumable product goal attainment through consultative selling, education and procedural support in an assigned territory and as a team member in identified key accounts. Assigned territory includes the state of Kansas and Oklahoma. Ideally, the successful candidate will be located in the Oklahoma City or Kansas City metropolitan areas. Qualifications - Minimum: - RCIS, RN, RT or related health care license - 3 years clinical experience in the interventional or peripheral cardiovascular laboratory or thorough knowledge of current interventional practices and procedures - Ability to conduct high impact presentations during training and customer presentations - Proven ability to demonstrate strong persuasive, objection handling and problem-solving skills in high pressure situations - Proven ability to demonstrate team contributor competencies: Action Oriented, Perseverance, Learning agility and attention to detail - Knowledge of computer applications including Word, Outlook, Excel and PowerPoint - Ability to manage multiple projects - Ability to work independently and exercise judgment consistent with organizational and department guidelines - Ability to learn and implement the Vital Signs process which includes completing baseline assessments per protocols outlined in the Account Database (Salesforce.com) - Preferred: - Bachelor’s degree - 5+ years of clinical experience in a diagnostic and interventional cardiovascular laboratory that utilizes the ACIST contrast delivery system - Sales experience a plus - Scrub experience preferred Requirements - Ability to lift equipment up to 50 pounds - Ability to travel a minimum of 70-80% of the time, including overnight travel to provide territory, regional and national support - Valid driver’s license - Must be able to meet and maintain customer/medical facility access requirements, including vendor credentialing requirements and regular or periodic drug screenings with a satisfactory result in accordance with the requirements of the customer/medical facility serviced Benefits - Estimated Beginning On Target Earnings: $138,000.00 - 149,000.00 - Total Rewards: - Paid Time Off, Company Holidays & Paid Family Leave - Achieve: Options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions - Live well: Comprehensive benefit options including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc. - Evolve: Opportunities for structured on-the-job learning, workshops, seminars, and tuition reimbursement program - Choose: Flexible working arrangements and business casual attire