• Assists Research Analysts with problem-solving and internal/external customer issues through roadblocks by providing enhanced reporting as necessary. • Coordinates and documents analysis processes to ensure the highest level of performance. • Evaluates department processes and requirements, evaluates alignment with organizational goals to optimize strategies, uncovers areas for improvement using quality trends, tracks trends, reports key findings to Research Management. • Works directly with Research Management to create and maintain a centralized repository of all Research reporting resources. • Monitors daily volume and collaborates with Research Management to ensure optimal efficiency and quality metrics are achieved and performance standards are met. • Prepares reports, statistics, agendas, and activities related to research and clients, including the calculation and reporting of daily efficiency for all team members. • Maintains a working knowledge of latest organizational processes and IT advancements to automate and/or modernize internal systems. • Handles confidential information responsibly and with good judgment; communicates with internal and external clients in a friendly but professional manner. • Manages competing resources and priorities. • Completes special projects as assigned. • Other duties as required.

Role Description The Quality Analyst is responsible for managing the various aspects of the medical file review process. They will review the completed referral to ensure client questions have been addressed appropriately and review the completed report for accuracy. Ensuring client and department standards have been met. Dane Street’s success relies on individual and team contributions every day. We care for our customers, each other and Dane Street. It is the responsibility for all of us to maintain a positive working environment that promotes client satisfaction and results. Qualifications - An Associate’s Degree or Bachelor’s Degree is preferred. Requirements - Business experience in a healthcare and/or insurance setting is preferred. - Working with technology based processes within the business environment. - Present exceptional communication skills with a clear understanding of company business lines. - The ability to apply critical thinking, manage time efficiently and meet specific deadlines. - Computer literacy and typing skills are essential. Benefits - Comprehensive benefits package designed to support your well-being and peace of mind. - Medical, dental, and vision coverage for you and your family. - Voluntary life insurance options for you, your spouse, and your children. - Other voluntary benefits including hospital indemnity, critical illness, accident indemnity, and pet insurance plans. - Basic life insurance, short-term disability, and long-term disability coverage at no cost. - Generous paid time off policy. - 401k plan with a company match. - Apple equipment and a media stipend for remote workspace. Working Conditions/Physical Demands - Any lifting, bending, traveling, etc. required to do the job duties listed above. - Long periods of sitting and computer work. Work From Home Technical Requirements - Supply and support their own internet services. - Maintaining an uninterrupted internet connection is a requirement of all work from home position.

**JOB SUMMARY** The Quality Analyst is responsible for managing the various aspects of the medical file review process. They will review the completed referral to ensure client questions have been addressed appropriately and review the completed report for accuracy. Ensuring client and department standards have been met. Dane Street’s success relies on individual and team contributions every day. We care for our customers, each other and Dane Street. It is the responsibility for all of us to maintain a positive working environment that promotes client satisfaction and results. **MAJOR DUTIES & RESPONSIBILITIES** * Quality Audits* - Reviews reports accompanying medical records to ensure that the report is complete and that all questions posed by the client have been addressed. - Follows up with the reviewer with any additional questions or clarifications needs. - Follows up with the client should there be any additional questions. - Updates clients frequently on referral progress. - Ensures the report is grammatically correct with no spelling errors. - Ensures each referral adheres to the QA checklist prior to the completion. - Formats reports for approval. * Communication* - Communicates clearly and concisely between the customer, reviewer, and Operations team - Must confidently speak with physicians and clients regarding the content of their peer reviews. Other duties & special projects, as assigned and based on business needs. ****

Title: Principal Biostatistician, Safety Analytics Job Description: Job: FSP Principal Biostatistician, Safety Analytics 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: - Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity, Injection/Infusion Site Reaction or other safety deliverables. - Support Safety Analytics and the study team on the delivery of Patient Profile display for Hepatic or other areas. - Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs. - Interrogating root cause of issues identified during ADaM/TFL/Interactive package review - 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 3+ years industry experience. - MS in Statistics, Biostatistics, or related field with 5+ years of industry experience. - At least 2 years of Phase 1, 2 and 3 clinical trial experience. - Strong experience reviewing ADaM datasets and TFLs (standard and customized output review). - Ability to follow data specifications and programming specifications and provide clear, actionable review comments. - Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors. - Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward. - R/SAS programming skills - Demonstrated ability to work pro-actively and independently. - Able to effectively communicate his/her ideas and to manage programmers in a constructive manner. - 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 $111,000.00 - $309,000.00. 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.