• Partner with medical for publication strategies, HEOR or economic modeling inputs • Provide statistical expertise in analyses using external control and/or synthetic control, meta-analyses, and causal inference analyses, e.g. propensity score matching method • Contribute to manuscripts, abstracts and presentations • Collaborate with HEOR to align analyses with HTA agency expectations • Review protocols for real world evidence studies • Work with statistical programmers to conduct ad hoc analyses; Conduct quality review of statistical analyses • Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs • Review relevant medical literature • Write statistical analysis plans • Develop TLF shells and review programming specs

Role Description We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Key Responsibilities: - Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas. - Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables. - Author and review key statistical documents, including: - Statistical Analysis Plans (SAPs) - Analysis Database Specifications (ADS) - Statistical sections of clinical study reports - Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance. - Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory. - Provide guidance and oversight to statistical programmers as needed. - Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders. - Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs. Qualifications - MS or PhD in Statistics, Biostatistics, or a related field. - Strong experience in Immunology or any TA clinical studies. - Hands-on experience writing: - Statistical Analysis Plans (SAPs) - Analysis Database Specifications - Reviewing and interpreting analysis results - SAS programming skills required (hands-on or strong working knowledge). - Excellent written and verbal communication skills. - Experience working in a CRO and/or pharmaceutical/biotech environment. Requirements - Experience leading Phase II–III clinical trials. - Prior interaction with regulatory agencies. - Experience mentoring junior statisticians or programmers. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Role Description As a Senior Clinical Research Associate you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance. - Conduct and report all types of onsite monitoring visits - Be involved in study startup (if applicable) - Perform CRF review, source document verification and query resolution - Be responsible for site communication and management - Supervise study activities, timelines, and schedules on the country level - Be a point of contact for in-house support services and vendors - Be involved in quality control, such as compliance monitoring and reports review - Participate in feasibility research - Support regulatory team in preparing documents for study submissions Qualifications - College/University degree in Life Sciences or an equivalent combination of education, training & experience - Independent on-site monitoring experience in the USA (5 years minimum) - Experience in all types of monitoring visits in Phase I-III - Participation in clinical projects as a Senior Monitor - Experience monitoring complex Oncology trials required; experience with radiopharmaceuticals and/or breast cancer preferred - Experience monitoring GI studies (IBD, Chron's, UC) is preferred - Full working proficiency in English - Proficiency in MS Office applications - Ability to plan, multitask and work in a dynamic team environment - Communication, collaboration, and problem-solving skills - Ability to travel up to 80% - Valid driver’s license (if applicable) Additional Information Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Title: Clinical Research Associate I Location: United States Texas Remote Clinical Monitoring ICON Strategic Solutions (FSP) Remote Job Description: Clinical Research Associate - Home-Based -Texas ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a CRA I at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programs. What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation - Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. - Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - University degree in medicine, science, or equivalent - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data - Excellent written and verbal communication in English - Good social skills enabling you to deal with queries in a timely manner - Willingness to travel as required (approximately 60%) What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family's needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here