• Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed • Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines • Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination • Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation • Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders • Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress • Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates • Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment • Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions • Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability

Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia. The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with sponsors, attending team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities - Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in Pre/Post-award process. - Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. - Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study. - Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies. - Establishes and maintains research files and documentation pertaining to regulatory requirement for clinical trials. - Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings. - Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date. - Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments. - Participates in required training and education programs and may provide training and education of other personnel. - May participate in centralized activities of the department or institution. - May plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP’s and/or job aids. - May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. - Ensures compliance with all federal and local agencies including the Food and Drug Administraton (FDA) and local Institutional Review Board. - Maintains research practices using Good Clinical Practice (GCP) guidelines. - Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

The Senior Biostatistician provides statistical support and leadership for oncology clinical trials across multiple phases of development. This role works closely with sponsors and cross-functional teams to support study design, protocol development, statistical analysis planning, data interpretation, and study reporting. The Senior Biostatistician is expected to contribute strong technical expertise, effective client communication, and high-quality delivery of statistical work products in a CRO environment.  Candidates with CRO experience are strongly preferred. Experience supporting oncology studies and Data Monitoring Committee (DMC/IDMC) activities is also preferred.  Essential Functions and Responsibilities - Provide statistical support for clinical trials from study start-up through final reporting and regulatory submission.   - Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy.   - Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents.   - Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the study lifecycle.   - Review statistical analyses and outputs, including tables, listings, and figures, to ensure quality, accuracy, and consistency.   - Support interim analyses, safety reviews, efficacy analyses, and final study reporting.   - Participate in the review of ADaM specifications, derived endpoints, and analysis datasets.   - Support the preparation of DMC materials, including review of analysis outputs and summaries for DMC meetings, in accordance with applicable procedures and confidentiality requirements.   - Interpret statistical results and communicate findings clearly to internal teams and sponsors.   - Ensure study deliverables are completed on time and in compliance with SOPs, regulatory requirements, and sponsor expectations.   - Support responses to sponsor questions, audit requests, and health authority queries related to statistical matters.   - Provide guidance to junior statisticians and support departmental process improvement and standardization efforts.   - Contribute to proposal development, bid defenses, and budget assumptions as needed.   Oncology-Specific Responsibilities  - Support oncology studies involving endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR.   - Contribute to statistical strategies for time-to-event analyses, censoring rules, subgroup analyses, and sensitivity analyses.   - Support studies using RECIST, iRECIST, or other disease-specific response criteria, as applicable.   - Work with cross-functional teams on tumor assessment data, adjudication, and endpoint derivation.   DMC / IDMC Experience - Support statistical activities related to DMC/IDMC reviews for ongoing clinical trials.   - Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials.   - Contribute to DMC charter review and statistical content, where applicable.   - Work effectively within blinded and unblinded team structures and maintain strict confidentiality.

Associate Biostatistician 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 are currently seeking an Associate Biostatistician to join our diverse and dynamic team. As an Associate Biostatistician at ICON, you will play a pivotal role in analyzing and interpreting clinical trial data, supporting the design of statistical analyses, and contributing to the development of high-quality reports. Your work will be integral to advancing clinical research and ensuring that data-driven insights support the development of innovative treatments and therapies. What You Will Be Doing: - Conducting statistical analyses and generating reports for clinical trials under the guidance of senior statisticians. - Collaborating with clinical teams to design and validate statistical methodologies for trial protocols. - Preparing and presenting statistical summaries and interpretations for regulatory submissions and internal meetings. - Ensuring data integrity and accuracy through rigorous statistical validation and quality control processes. - Assisting in the development of statistical programming and analysis plans in accordance with regulatory guidelines. Your Profile: - Master’s degree in Statistics, Biostatistics, or a related field. - Experience with statistical software such as SAS, R, or similar tools. - Understanding of clinical trial design and statistical methods applicable to clinical research. - Strong analytical skills with a keen attention to detail and accuracy. - Excellent communication skills and the ability to work collaboratively within multidisciplinary teams. #LI-JJ1 #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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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