• Participate in the development, conduct and reporting of corporate/global clinical trials • Understand and keep updated with the pre-clinical and clinical data relevant to the product(s) • Collaborate with the appropriate leaders in the development and maintenance of clinical strategy • Plan, collaborate on, and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions • Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events • Participate in development and review of label changes and labeling modifications

Title: Senior Principal Biostatistician Location: Blue Bell United States Job Description: JR142577 - Biostatistician - ICON Full Service & Corporate Support - Remote or Office About the role Senior Principal Biostatistician (Oncology Early Phase) - United States Remote 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. We have an incredible opportunity for a Senior Principal Biostatistician to join ICON’s Full-Service Emerging Oncology Biotech team. The Senior Principal Biostatistician will lead and oversee small to medium sized and simple to high complex Phase I-II clinical trials. They will provide input to statistical components including protocol, mock shells, SAP text, programmed deliverables, and CSR. Location: Remote - United States - Canada What you will be doing: - Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies - Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies - Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports - Program using SAS and/or R for inferential statistics - Participate in bid defense meetings and make presentations at meetings with prospective clients - Mentor or provide support to junior statisticians - Lead or partake in initiatives to improve internal processes or create new guidance Your profile: - Master's degree or Ph.D in Biostatistics, Statistics, or a related field - 8+ years of biostatistical experience, preferably in a clinical research organization - Experience leading Phase I/II Oncology studies, including client facing responsibilities, timeline management, and resource oversight - Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications) - Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies - Effective written and oral communication skills with demonstrated leadership ability - Ability to prioritize with strong time management skills #LI-TP1 #LI-Remote 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. Visit our careers site to read more about the benefits ICON offers. 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 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

What You'll Do: This role is vital to our organization's mission and growth, and if selected, you'll work on the following challenging and interesting projects: - Become a subject matter expert in both client and Fusion applications, workflows and processes. - Work with complex healthcare workflows, demonstrating knowledge of integrated workflows, applications and problem analysis to provide system solutions for organizational needs. - Enhance customer insights by actively engaging with end-users, analyzing trends, and leveraging data to drive customer-centric decisions and product innovation - Collaborate with key stakeholders to gather requirements and design customized EHR solutions that meet the specific needs of the organization. - Configure and customize EHR workflows to align with clinical and administrative processes. - Collaborate with cross-functional teams by actively engaging with teams, sharing expertise, and aligning on project objectives to ensure seamless client and new product implementations. - Work to foster continuous improvement by identifying challenges, generating creative solutions, and contributing to product innovations that enhance client growth and efficiency. - Communicate project progress, challenges, and solutions effectively to stakeholders. - Adhere to HIPAA regulations for transactions, security and confidentiality. Who You Are: We believe in harnessing diverse talents and perspectives, and if you believe you have what it takes to excel in this role, we want to hear from you. We look forward to reviewing your application if you have the following qualifications and experience: - Nursing or clinical background required. - Knowledge of correctional healthcare is preferred. - Bachelor's degree in a healthcare related field preferred. - 2-4 years of experience in a similar role - Proven experience in EHR system implementation and support. - Strong understanding of healthcare operations and clinical workflows. - Knowledge of healthcare regulations, including HIPAA. - Proficiency in EHR software, clinical workflows and client management. - Excellent communication and interpersonal skills. - Strong problem-solving abilities. - Attention to detail and commitment to quality. - Ability to work independently and in a team environment. - Willingness to travel on site to client facilities is preferred. - Relevant certifications, such as Certified Correctional Health Professional (CCHP) are a plus. Additional Details: - This is a remote, full time, salaried role. - Our normal hours of operation are Monday – Friday, 8:00 AM – 4:00 PM EST or CST - This position description is not intended to be exhaustive, and other duties may be assigned as they arise. - It is not expected that applicants have any familiarity with Fusion’s proprietary applications, Healthcare software, or Corrections/Public Health business processes. Qualified candidates will be able to demonstrate related experience and transferable skills that will work well with the Fusion team. - At this time, this position is not eligible for employment sponsorship. - Fusion is an equal employment opportunity employer. Compensation: - Salary Range: $80,000 - $100,000 - At Fusion, our salary ranges are designed to be competitive within our size and industry. Compensation is just one component of a comprehensive total rewards package that also includes benefits, flexibility, and growth opportunities. - Individual pay decisions are informed by several factors, including location, experience, qualifications, skillset, and internal equity across the organization. While we expect most offers to fall within the stated range, each compensation decision is made thoughtfully, with consideration for both the candidate’s unique profile and our commitment to pay parity. For Internal Use only: In reference to our Employee Referral Program, this opening is: Level 4

What You'll Do We’re looking for a Recruitment Coordinator to provide research support for clinical studies run by Carbon Health’s clinical research program, Carbon for Research. If you are passionate about clinical research and want to be part of building our clinical research division and part of a rapidly growing company, then this is the role for you. In this role, you’ll partake in clinical research studies from initiation to completion. You will conduct day to day operations of clinical research recruitment and retention. You’ll work closely with Principal Investigators, co-investigators, our clinical research supervisor, clinical research coordinators, clinics and its staff for each study that you are supporting, along with the Launchpad (HQ) team. There will be peak periods during the year with high workloads due to overlapping deadlines and time sensitive priorities. This role is a 100% remote position. BENEFITS - Medical, dental & vision coverage, effective first day of employment - Health Savings Account & Flexible Savings Account option for health care & dependent care - Paid time off, paid sick leave - 401k retirement savings plans with employer match - Life & Disability Insurance - DOT certification will be reimbursed where it is required for practice *Some benefits dependent on specialty and employment status We recognize that the key to success lies in valuing the minds, experiences and perspectives of people from all walks of life. Carbon Health is proud to value diversity and be an equal opportunity employer. Pursuant to the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring, we will consider for employment qualified applicants with arrest and conviction records. Carbon Health is an E-Verify employer.