Job: FSP Principal Biostatistician, Safety Location: Home-based in the U.S. or Canada Why DSSS? Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market. Job Summary: The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes. Additional Benefits: - Home-based remote working opportunities. - Work/life balance as well as flexible schedules. - Collaborating with motivated, high-performance, statistical and research teams. - Technical training and tailored development curriculum. - Research opportunities that match your unique skillset. - Promising career trajectory. - Job stability: long-term engagements and re-deployment opportunities. - Focus on bringing new therapies to market rather than project budgets and change orders. - Experience with regulatory submissions. - Engaging, fast-paced environment. - Good work-life balance. Job Responsibilities: - Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials. - Collaborate with multi-disciplinary project teams to establish project objectives and timelines. - Participating in study design discussions, including protocol development - Write the statistical sections of clinical trial protocols. - Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed. - Developing and reviewing statistical analysis plans and TFL templates. - Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. - Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. - Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc. - Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements. - Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures. - Perform exploratory safety analyses - Perform validation of analysis variables and statistical outputs - Interpret study results and review reports of study results for accuracy. - Present, communicate and interpret safety analyses to study teams - Support exploratory analyses. - Participate in pre-IND or NDA activities. Qualifications (Minimal acceptable level of education, work experience, and competency) - PhD in Statistics, Biostatistics, or related field with 5+ years industry experience. - MS in Statistics, Biostatistics, or related field with 7+ years of industry experience. - At least 5 years of Phase 1, 2 and 3 clinical trial experience. - Demonstrated ability to work pro-actively and independently. - Able to effectively communicate his/her ideas and to manage programmers in a constructive manner. - Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary. - Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. - Experience with CDISC, including SDTM, ADAM, CDASH Desired Experience: - Leading DSBM or DMC for biostatistics #LI-Remote #LI-NITINMAHAJAN IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $105,800.00 - $294,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Job Title: Registered Dietitian – Clinical Research Support Location: Remote (France) Job Type: Freelance / Part-time (ad hoc hours) Are you ready to make a real impact? Do you want to work flexibly from anywhere in France, while advancing your career with a global leader in healthcare innovation? Join IQVIA and become part of a collaborative, forward-thinking team that values your expertise and supports your professional growth. IQVIA is seeking experienced and registered Dietitians to join our team for an international clinical research projects in the field of metabolic disease area. You will support patients participating in clinical studies, provide nutritional and lifestyle guidance, and contribute to improving healthcare outcomes. Key Responsibilities - Conduct comprehensive nutritional assessments - Provide ongoing counseling and motivational support to study participants - Monitor participant progress and outcomes throughout the study period - Conduct all meetings and consultations with participants online (telehealth) - Collaborate with the clinical research team to ensure adherence to study protocols - Maintain accurate and confidential documentation in compliance with regulatory standards - Participate in virtual team meetings and training sessions Requirements - Certified and Registered Dietitian - Fluent in English; additional language skills are a plus - Strong interpersonal and communication skills - Ability to work independently and in a structured manner; clinical experience preferred - Proficient with digital tools and telehealth platforms What We Offer - Opportunity to contribute to a high-impact international clinical study - Remote work and collaboration with an international team - All participant interactions and monitoring are conducted online - Professional development and exposure to global research standards Why IQVIA? At IQVIA, you’ll be part of a collaborative and forward-thinking team that’s shaping the future of healthcare. We offer a supportive environment, meaningful work, and the chance to grow your career in clinical research. #LI-DNP #LI-CES #LI-HCPN #LI-XS IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving the execution of Lilly clinical trials through exceptional investigator engagement and site performance management. This role is pivotal in ensuring Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight. CRLs combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies in existing and new therapeutic areas. They serve as trusted partners to investigators—building strong, enduring relationships that improve return on enrollment and position Lilly as the sponsor of choice. CRLs partner closely with internal Lilly teams (including Clinical Development and Medical Affairs) to ensure that insights from the field shape development strategies and that development strategies are delivered with operational excellence and scientific clarity. Where applicable the CRL may also represent Investigator Engagement with Regulatory and External Bodies and help shape the country-level clinical trial landscape. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Clinical Investigator Management - Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout - Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements - Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas - Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives - Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc - Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct Clinical Trial Management - Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery - Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones - Drive inspection readiness as a continuous discipline across sites - Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality - Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization - Provide oversight and quality assurance for vendor monitoring, escalating risks proactively - Where applicable, lead end-to-end management of Post-Marketing Safety Studies in compliance with local regulations Business Management and Engagement - Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize Lilly trials - Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner - Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity - Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution - Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel - Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer - Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships Country / Regulatory Engagement (where applicable) - Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations in countries/territory - Influence the clinical trial ecosystem to improve regulatory agility and operational feasibility - Ensure that local requirements are translated into compliant, efficient trial execution and that Lilly’s internal processes reflect evolving country landscapes - Partner with leadership to identify and align regional initiatives and contribute to enterprise-wide clinical development success Minimum Qualification Requirements: - Bachelor’s degree or equivalent; strong preference for scientific, clinical, or health-related fields - Minimum 5 years of experience in clinical research or pharmaceutical industry with experience directly interacting with or working with HCPs and clinical sites - Minimum 2 years of relevant clinical or deep therapeutic area experience in Oncology - Currently reside in or be willing to relocate to our designated Midwest region (Colorado, Utah, Missouri, Kansas, Nebraska, Wyoming) Other Information/Additional Preferences: - Advanced degree in a scientific or clinical field (PharmD, PhD, MD, or MSc preferred) - Excellent understanding of GCP, clinical development and operations, and trial lifecycle - Demonstrated understanding of the therapeutic landscape and standards of care, with the ability to apply this knowledge to decision making - Proven ability to build credibility and influence HCP community through scientific acumen and relationship strength - Strategic approach with demonstrated success in delivering results in complex, fast-paced environments - Data-driven decision-making skills; ability to interpret and act on performance and operational metrics - Excellent communication, negotiation, and organizational skills - Deep therapeutic area knowledge and familiarity with local clinical research ecosystems - Experience directly influencing clinical site performance and driving enrollment success - Track record of delivering or exceeding performance targets in a collaborative matrix environment - Experience working with regulators or national bodies in support of clinical trial delivery - English fluency and proficiency in local language(s) as needed Travel Requirements: - Willingness to travel extensively (60-80%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

About the Role The Clinical Excellence Lead III is an independently licensed behavioral health clinician who reports to the Clinical Excellence Manager. This clinical leadership role delivers evidence-based interventions via the Collaborative Care Model to individuals (pediatric and/or adult populations) experiencing mild to moderate symptoms and utilizes evidence-based therapeutic approaches to promote symptom reduction and optimal patient outcomes, while also overseeing the performance and development of Collaborative Care Clinicians. Administrative Responsibilities: - Direct oversight of up to 15 Collaborative Care Clinician’s performance including clinical metrics, schedule management, coaching, performance management, and clinical supervision - Responsible for supporting pod and partner workflows and needs in partnership with the Clinical Excellence Manager - Manages employee schedules including shift coverage for assigned practices, approving time off and vacation requests, and ensuring the attendance policy is being adhered to - Supervises and mentors employees including patient care, performance evaluations, development of career goals, and disciplinary action, including and up to termination - Partners with Clinical Excellence Manager to ensure department objectives are being met; recommends ways to improve efficiency and minimize barriers - Serves as a resource to direct reports in resolving and documenting complex patient situations including escalated complaints, patient terminations, and incident reporting. - Responsible for keeping an open line of communication with all Clinical Excellence Managers, Market Lead, and others in management - Handles escalated employee relations concerns with guidance from the Clinical Excellence Manager and Associate Clinical Director Clinical Responsibilities: - Will manage a small caseload (no more than 15 patients) based on needs of assigned Care Pod, customizing treatment plan to individual patient needs - Supports and closely coordinates behavioral health care with the patient’s primary care provider and (when appropriate) other service providers - Screens and assesses patients for common behavioral health and substance use disorders using PHQ9, GAD7, Columbia Suicide Risk Assessment, or other tools as required - Monitors patients for changes in clinical symptoms and treatment side effects/complications, with a goal of reduction in symptoms - Supports psychotropic medication management prescribed by PCPs, focusing on treatment adherence, side effects and other complications, and treatment effectiveness - Tracks patient follow-up and clinical outcomes using a registry, records encounters in the registry and uses the system to identify and re-engage patients - Plans specific mutual self-management goals, objectives, and interventions with action-oriented patients - Facilitates care plan changes for patients who are not improving, including changes in medications or psychosocial treatments or appropriate referrals for additional services - Documents patient progress and treatment recommendations in Salesforce and the electronic health record so they can be easily shared with primary care providers, the psychiatric consultant, and other treating providers - Completes relapse prevention plan with patients who are in remission - Educates patients about behavioral health/substance use disorders/treatment options - Establishes mutually agreeable care management plan with the care team and patient/family - Participates in regularly scheduled caseload consultations with psychiatric consultants Required Qualifications: - Masters degree in social work, counseling, or related field - Licensed to practice in the state of California as an independent clinician (LCSW, LPCC, or equivalent) - Additional state licenses and/or willingness to acquire additional licenses - Minimum of 5+ years of clinical experience - Minimum of 3+ years of lead or supervisory experience - Proficiency in evidence-based treatment approaches (Problem-Solving Treatment, Motivational Interviewing, Cognitive Behavioral Therapy, and Behavioral Activation). - Technical proficiency in a variety of platforms including EHRs, ability to quickly learn new technology - Knowledge of/experience with behavioral health tools (PHQ9, GAD7, CSSRS, etc.) - Capability to provide clinical care to patients in primary care settings, including those as young as 6 years old, as well as in women's health - Knowledge of CoCM Preferred Qualification: - Fluent in both English & Spanish preferred Benefits: - 100% remote with employer supplied computer equipment - Opportunities for Supervision - Work/life balance with 10 paid holidays, sick time, and additional PTO plans - Medical, Dental, and Vision plans effective on the first day of employment - Employer paid Short Term Disability and Long Term Disability plans - Employer paid Life and AD&D insurance of $50,000 - Employer paid Parental Leave of 12 weeks - 401K Compensation: - Annualized base salary is determined by geographic location and budget and is paid on a biweekly basis: $75,000.00 - $106,356.80 - 10% annual bonus potential Schedule: - Monday - Friday | 11:00am - 7:00pm Pacific Time - 100% Remote Concert Health is a diverse and inclusive Equal Opportunity Employer; we prohibit discrimination and harassment of any kind in our culture. We are dedicated to providing a safe, equitable, respectful, and supportive work environment to all without regard to race, color, religion, sex, gender, national origin, age, pregnancy, disability, sexual orientation, military or veteran status, genetics, or any other status protected by federal, state, or local laws. This policy applies to all terms and conditions of work, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. All Concert Health employees are expected to comply with this policy. If you share our vision and are good at what you do, come as you are. You are welcome here.