"Ce message est publié en prévision d'un rôle futur." French Job Description Niveau d'emploi : Biostatisticien principal FSP pour le secteur pharmaceutique RWE Localisation : Travail à domicile aux États-Unis ou au Canada Pourquoi DSSS ? Data Sciences Staffing Solutions, DSSS, est une unité au sein d'IQVIA qui fournit à nos sponsors des ressources entièrement intégrées via un partenariat de fournisseur de services fonctionnels (FSP). Cela signifie que vous bénéficiez de tous les avantages de travailler pour un CRO mondial leader du secteur tout en collaborant directement avec des équipes de sponsors interfonctionnelles expertes. Les clients sponsors comprennent des sociétés pharmaceutiques et biotechnologiques de classe mondiale qui vous offrent des opportunités uniques d’influencer l’avenir de la médecine et de faire progresser les thérapies sur le marché. Résumé du poste : Le biostatisticien principal est chargé de fournir un soutien statistique à la nouvelle recherche clinique. Avantages supplémentaires : - Possibilités de travail à distance à domicile - Équilibre travail/vie personnelle ainsi que des horaires flexibles. - Collaborer avec des équipes de statistiques et de recherche motivées et performantes - Formation technique et programme de développement sur mesure - Opportunités de recherche qui correspondent à vos compétences uniques - Un parcours professionnel prometteur - Stabilité d'emploi : engagements à long terme et opportunités de redéploiement - Concentrez-vous sur la mise sur le marché de nouveaux traitements plutôt que sur les budgets de projet et les modifications d'ordres. - Expérience avec les soumissions réglementaires. - Environnement engageant et dynamique. - Bon équilibre travail-vie personnelle. Responsabilités du poste : Accès et collecte des données : - Identifiez et accédez à diverses sources RWD, telles que les dossiers de santé électroniques (DSE), les bases de données de réclamations, les registres de patients et d'autres référentiels de données du monde réel. - Collaborer avec les fournisseurs de données et les organisations de soins de santé pour garantir la qualité, la conformité et l'accessibilité des données. - Développer des pipelines de collecte de données robustes en utilisant des techniques de programmation avancées pour soutenir les objectifs de l'étude. - Analyse des données et modélisation statistique : - Concevoir et exécuter des analyses statistiques de RWD pour générer RWE à des fins cliniques, réglementaires et commerciales. - Appliquer des méthodes statistiques avancées, notamment l'appariement des scores de propension, l'analyse de survie, la modélisation de régression et l'apprentissage automatique, pour obtenir des informations significatives. - Tirer parti de solides compétences en programmation pour développer, valider et optimiser des modèles analytiques et des scripts pour des ensembles de données RWD complexes. - Mener des recherches comparatives sur l'efficacité, des études sur les résultats en matière de santé et des analyses pharmacoéconomiques, en abordant des problèmes tels que les confusions, les biais et les données manquantes. Conception de l’étude et développement de protocoles : - Collaborer avec des équipes interfonctionnelles pour concevoir des études RWE, y compris des études de cohorte rétrospectives, des études cas-témoins et des essais pragmatiques. - Contribuer aux protocoles d'étude, aux plans d'analyse statistique (SAP) et aux rapports techniques, en garantissant que les éléments de programmation sont clairement définis. - Veiller à ce que les études soient conformes aux normes réglementaires (par exemple, FDA, EMA) pour les soumissions RWE. Rapports et communications : - Préparer des rapports, des manuscrits et des présentations de haute qualité résumant les conclusions de RWE pour les parties prenantes internes, les autorités réglementaires et les publications évaluées par des pairs. - Utiliser vos compétences en programmation pour créer des outils de reporting automatisés et des visualisations de données dynamiques pour un public non technique. - Fournir des recommandations stratégiques basées sur RWE pour soutenir le développement de médicaments, l'accès au marché et la gestion du cycle de vie. Conformité et assurance qualité : - Démontrer une solide compréhension et assurer le respect des directives réglementaires (par exemple, FDA 21st Century Cures Act, cadre EMA RWE) et des normes de l'industrie (par exemple, ISPOR, ISPE), telles qu'applicables aux statistiques. - Mettre en œuvre les meilleures pratiques en matière d'intégrité, de reproductibilité et de transparence des données grâce à un code bien documenté et efficace. - Effectuer le contrôle de qualité et la validation des résultats statistiques et de programmation. Qualifications - Doctorat en statistiques, biostatistiques ou dans un domaine connexe avec plus de 5 ans d'expérience dans l'industrie. - Expertise avérée dans les études RWD/RWE, avec une expérience pratique de l'analyse des DSE, des données de réclamation, des registres ou d'autres sources de données du monde réel. - Expérience avec différentes conceptions d'études, l'élaboration de protocoles et la rédaction de plans d'analyse statistique - Expérience démontrée en matière de soutien aux soumissions réglementaires (par exemple, FDA, EMA) en utilisant RWE. - Excellentes compétences en résolution de problèmes et en pensée critique. - Solides capacités de communication et de collaboration pour travailler avec des équipes interfonctionnelles et des partenaires externes. - Capacité à gérer plusieurs projets et à respecter les délais dans un environnement en évolution rapide. - Expérience en modélisation statistique de données cliniques et en inférence statistique - Solides compétences en programmation : maîtrise avancée des langages de programmation statistique tels que R, Python ou SAS pour la manipulation de données, l'analyse statistique et l'automatisation. - Expérience avec l'interrogation de bases de données (par exemple, SQL) et la gestion d'ensembles de données volumineux et complexes. - Familiarité avec les outils de visualisation de données (par exemple, Tableau, Power BI ou R Shiny) pour créer des présentations percutantes des résultats de RWE. - Connaissance des systèmes de contrôle de version (par exemple, Git) et des pratiques de recherche reproductibles. - Maîtrise de l'application de méthodologies statistiques pour le RWD, y compris les méthodes de score de propension, l'analyse de données longitudinales et les techniques d'inférence causale. - Basé sur un fuseau horaire aux États-Unis ou en Europe (UTC-8 à UTC+2) pour faciliter la collaboration en temps réel - Compréhension de ICH GCP, ICH E9 et connaissance générale des pratiques et normes de l'industrie. - Expérience avec CDISC, y compris SDTM, ADAM, CDASH. Expérience souhaitée : Aucune autre compétence spécialisée n’est applicable. Remarque - Nous avons des rôles de statisticien principal dans tous les domaines du FSP - Phase précoce et Phase tardive, alignés sur diverses études thérapeutiques. "This is posted in anticipation of a future role" English Job Description- Job Level: FSP Principal Biostatistician for Pharmaceutical RWE Location: Home-based in US/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 means you get all the benefits of working for an industry leading global CRO while collaborating directly with expert 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 novel clinical research. 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: Data Access and Collection: - Identify and access diverse RWD sources, such as electronic health records (EHRs), claims databases, patient registries, and other real-world data repositories. - Collaborate with data vendors and healthcare organizations to ensure data quality, compliance, and accessibility. - Develop robust data collection pipelines using advanced programming techniques to support study objectives. Data Analysis and Statistical Modeling: - Design and execute statistical analyses of RWD to generate RWE for clinical, regulatory, and commercial purposes. - Apply advanced statistical methods, including propensity score matching, survival analysis, regression modeling, and machine learning, to derive meaningful insights. - Leverage strong programming skills to develop, validate, and optimize analytical models and scripts for complex RWD datasets. - Conduct comparative effectiveness research, health outcomes studies, and pharmacoeconomic analyses, addressing issues like confounding, bias, and missing data. Study Design and Protocol Development: - Collaborate with cross-functional teams to design RWE studies, including retrospective cohort studies, case-control studies, and pragmatic trials. - Contribute to study protocols, statistical analysis plans (SAPs), and technical reports, ensuring programming components are clearly defined. - Ensure studies align with regulatory standards (e.g., FDA, EMA) for RWE submissions. Reporting and Communication: - Prepare high-quality reports, manuscripts, and presentations summarizing RWE findings for internal stakeholders, regulatory authorities, and peer-reviewed publications. - Use programming skills to create automated reporting tools and dynamic data visualizations for non-technical audiences. - Provide strategic recommendations based on RWE to support drug development, market access, and lifecycle management. Compliance and Quality Assurance: - Demonstrate strong understanding of and Ensure compliance with regulatory guidelines (e.g., FDA 21st Century Cures Act, EMA RWE framework) and industry standards (e.g., ISPOR, ISPE), as applicable to statistics. - Implement best practices for data integrity, reproducibility, and transparency through well-documented and efficient code. - Perform quality control and validation of statistical and programming outputs Qualifications - PhD in Statistics, Biostatistics, or related field with 5+ years industry experience. - Proven expertise in RWD/RWE studies, with hands-on experience analyzing EHRs, claims data, registries, or other real-world data sources. - Experience with different study designs, protocol development, and statistical analysis plan writing - Demonstrated track record of supporting regulatory submissions (e.g., FDA, EMA) using RWE. - Excellent problem-solving and critical-thinking skills. - Strong communication and collaboration abilities to work with cross-functional teams and external partners. - Ability to manage multiple projects and meet deadlines in a fast-paced environment. - Experience with statistical modelling of clinical data and statistical inference - Strong Programming Skills: Advanced proficiency in statistical programming languages such as R, Python, or SAS for data manipulation, statistical analysis, and automation. - Experience with database querying (e.g., SQL) and managing large, complex datasets. - Familiarity with data visualization tools (e.g., Tableau, Power BI, or R Shiny) to create impactful presentations of RWE findings. - Knowledge of version control systems (e.g., Git) and reproducible research practices. - Proficiency in applying statistical methodologies for RWD, including propensity score methods, longitudinal data analysis, and causal inference techniques. - Based in a time zone within the United States or Europe (UTC-8 to UTC+2) to facilitate real-time collaboration - Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. - Experience with CDISC, including SDTM, ADAM, CDASH. Desired Experience: - No further specialized skills are applicable. Note--We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies. #LI-Remote #LI-NITINMAHAJAN IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez https://jobs.iqvia.com IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au workday_recruiting@iqvia.com, afin qu’IQVIA puisse soutenir votre participation au processus de recrutement. IQVIA s’engage à faire preuve d’intégrité dans son processus de recrutement et applique une politique de tolérance zéro en matière de fraude des candidats. Toutes les informations et toutes les qualifications soumises dans votre candidature doivent être véridiques et complètes. Toute fausse déclaration, présentation trompeuse ou omission importante au cours du processus de recrutement entraînera la disqualification immédiate de votre candidature, ou la cessation d’emploi si elle est découverte ultérieurement, conformément aux lois applicables. Nous apprécions votre honnêteté et votre professionnalisme. Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe. 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, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: workday_recruiting@iqvia.com, so that IQVIA can support your participation in the recruitment process. 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. Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making. La fourchette salariale de base potentielle pour ce poste, annualisée, est de $116,300.00 - $235,400.00. Le salaire de base réel offert peut varier selon plusieurs facteurs, notamment les qualifications liées à l’emploi telles que les connaissances, les compétences, la formation et l’expérience; l’emplacement; et/ou l’horaire (temps plein ou temps partiel). Selon le poste offert, des régimes d’incitation, des primes et/ou d’autres formes de rémunération peuvent être proposés, en plus d’une gamme d’avantages sociaux liés à la santé, au bien-être et/ou d’autres bénéfices. The potential base pay range for this role, when annualized, is $116,300.00 - $235,400.00. 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 wellness and/or other benefits.

Role Description The Outpatient Clinical Documentation Integrity (CDI) Specialist supports accurate, complete, and compliant provider documentation in ambulatory settings. This role focuses on chronic condition capture, risk adjustment accuracy, quality reporting, and provider education to ensure documentation reflects the true clinical complexity of the patient population. Essential Duties and Responsibilities - Review outpatient encounters (pre visit, concurrent, and/or post visit) to assess documentation accuracy and completeness. - Identify opportunities for improved documentation related to: - Chronic conditions and disease specificity - Risk adjustment (e.g., HCCs) - Quality measures and medical necessity - Provide compliant documentation clarification via query and feedback to providers through approved communication channels. - Support accurate problem list management and ongoing condition validation. - Collaborate with coding, quality, compliance, and revenue cycle teams as needed. - Track and report CDI interventions, trends, and outcomes. - Participate in provider education and training initiatives. - Stay current on outpatient coding, risk adjustment, and regulatory guidance. Compliance & Regulatory Oversight - Ensure compliance with CMS, payer, and organizational documentation and billing requirements. - Identify potential compliance risks, including but not limited to overcoding, undercoding, and missing and/or unsupported diagnoses. - Apply knowledge of HCCs, risk adjustment, quality measures, and outpatient reimbursement methodologies as applicable. Qualifications - An active coding credential required such as - RHIA, RHIT, CPC, COC, CCS-O, CCS, CDEO, CCDS, CDIP or CCDS-O. - 3+ years of outpatient coding, risk adjustment, outpatient CDI. - Strong understanding of: - ICD‑10‑CM outpatient coding - Risk adjustment models (e.g., Medicare Advantage HCCs) - Outpatient E/M documentation requirements - Experience working in an ambulatory EHR (Epic, Cerner, or similar). Skills & Competencies - Strong clinical and analytical judgment. - Professional communication style. - Excellent written documentation skills. - Comfortable working independently in a fast-paced environment. - Proficient in Microsoft Office Applications. Physical Demands - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions as described. - Regular eye-hand coordination and manual dexterity is required to operate office equipment. - The ability to perform work at a computer terminal for 6-8 hours a day and function in an environment with constant interruptions is required. - At times, Team Members are subject to sitting for prolonged periods. - Infrequently, Team Member must be able to lift and move material weighing up to 20 lbs. - Team Member may experience elevated levels of stress during periods of increased activity and with work entailing multiple deadlines.

Are you an internal caregiver, student, or contingent worker/agency worker at UMass Memorial Health? CLICK HERE to apply through your Workday account. Exemption Status: Exempt Hiring Range: $87,276.80 - $157,081.60Please note that the final offer may vary within this range based on a candidate’s experience, skills, qualifications, and internal equity considerations. Schedule Details: Monday through Friday Scheduled Hours: 40 hours Shift: 1 - Day Shift, 8 Hours (United States of America) Hours: 40 Cost Center: 99940 - 5401 Clinical Documents Specialists This position may have a signing bonus available a member of the Recruitment Team will confirm eligibility during the interview process. Everyone Is a Caregiver At UMass Memorial Health, everyone is a caregiver – regardless of their title or responsibilities. Exceptional patient care, academic excellence and leading-edge research make UMass Memorial the premier health system of Central Massachusetts, and a place where we can help you build the career you deserve. We are more than 20,000 employees, working together as one health system in a relentless pursuit of healing for our patients, community and each other. And everyone, in their own unique way, plays an important part, every day. Drawing upon clinical knowledge and experience, closely collaborates with physicians and other team members to ensure that patient records accurately document the status, complexity and intensity of patient conditions and care. Drawing upon clinical knowledge and experience, closely collaborates with physicians and other team members to ensure that patient records accurately document the status, complexity and intensity of patient conditions and care. Major Responsibilities: - Works collaboratively with physicians, nurses, and other staff to ensure accurate and complete medical record documentation to appropriately reflect severity of illness and risk of mortality. - Reviews inpatient medical records for identified payer populations or clinical specialties upon admission and throughout hospitalization. Analyzes clinical status of patient, current treatment plan and past medical history and identifies potential gaps in physician documentation. - Communicates with attending physicians either verbally or electronically to validate observations and suggest additional and/or more specific documentation. - Supports Physician leaders with focused documentation reviews and special projects as directed. - Supports appropriate documentation for coding, reimbursement and quality purposes. Position Qualifications: License/Certification/Education: Required: - Massachusetts licensure as a registered nurse required Preferred: - Bachelor’s degree preferred Experience/Skills: Required: - Experience in direct patient care, case management, utilization review or equivalent required. - Knowledge of clinical documentation practices and principles and ICD-10-CM diagnosis codes required. - Excellent interpersonal skills and demonstrated ability to interact with physicians in a collaborative and professional manner. - Ability to effectively use specialized computer based systems for gathering, reporting, and analyzing critical data. Preferred: - 1-3 years of CDI experience preferred All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. We’re striving to make respect a part of everything we do at UMass Memorial Health – for our patients, our community and each other. Our six Standards of Respect are: Acknowledge, Listen, Communicate, Be Responsive, Be a Team Player and Be Kind. If you share these Standards of Respect, we hope you will join our team and help us make respect our standard for everyone, every day. As an equal opportunity and affirmative action employer, UMass Memorial Health recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, protected veteran status or other status protected by law. If you are unable to submit an application because of incompatible assistive technology or a disability, please contact us at talentacquisition@umassmemorial.org. We will make every effort to respond to your request for disability assistance as soon as possible.

Title: Documentation Specialist Location: NJ, Manchester, Lakehurst Part time Job Description: Shape the future of defense with MANTECH! Join a team dedicated to safeguarding our nation through advanced tech and innovative solutions. Since 1968, we’ve been a trusted partner to the Department of Defense, delivering cutting-edge projects that make a real impact. Dive into exciting opportunities in Cybersecurity, IT, Data Analytics and more. Propel your career forward and be part of something extraordinary. Your journey starts now—protect and innovate with MANTECH! MANTECH seeks a motivated, career customer-oriented Documentation Specialist to join our team in Lakehurst, NJ. This is a part-time, hybrid position requiring 1 days in office and 3 days remote. Responsibilities include but are not limited to: - Receive engineering technician’s drawing reviews and recommendations notes in MS Word format for the technical drawing package. Enter technician notes into the appropriate sections of technical drawing package. - Receive Government provided Quality Assurance documentation in MS Word Format. - Merge the MS Word Technical Drawing Package and Quality Assurance documents. Review the merge documents to correct formatting errors, insertion of page numbers and editing for page overruns. Example: resize table rows or cells to eliminate white space. Must have advanced formatting skills. - Convert finish MS Word merged document into PDF format. - In Adobe Pro, merge PDF cover page and newly created document. Edit and format document as needed and save as a PDF document. Send completed PDF file to MANTECH Technicians for final review and submittal to the government. - Enter data and maintain Excel program databases and spreadsheets. - Upload documentation developed and any changes into the existing database repository. - Enter and link part numbers and maintain a part number sort file in Excel for each program documentation package. Update as required for accuracy based on any changes received from customer review of documentation packages. - Work closely with existing project team to achieve tight, fast paced turnaround schedules for documentation package responses to government assigned drawings tasked for review. Minimum Qualifications: - High school diploma - 3+ years of experience in the area of word processing to include forms, reports and polished documents. - Experience with Microsoft Word to include extensive knowledge with formatting of documents and converting Microsoft Word documents to PDF. - Experience in editing and formatting of documents using Adobe Pro. - Experience with Microsoft Excel to support updating spreadsheets, insertion of rows and searching for Part Numbers. Preferred Qualifications: - Experience with Aircraft Launch and Recovery Equipment (ALRE) or Department of Defense Logistics Systems. - Experience as a Word Processor. - Experienced and fluent in use of MS Office (Word, Excel) and Adobe Pro. - Experience in combining (marrying) document elements such as the technician’s review comments in MS Word, QA sheet in MS Word and attaching a Cover sheet into a single PDF document, with page numbers, to prepare for submission to customer. - Ability to accomplish QA of completed PDF document to ensure all technician and government comments and notes have been incorporated. - Detail oriented, accurate and quality focused in preparing documentation packages. Clearance Requirements: - U.S. Citizenship required and an active Secret security clearance or ability to get an Interim Secret before starting Physical Requirements: - Must be able to remain in a stationary position 50% of the time. - Needs to occasionally move about inside the office to access file cabinets, office machinery, etc. - Frequently communicates with co-workers, management, and customers via verbal and email correspondences. The projected compensation range for this position is $41,700.00-$68,600.00. There are differentiating factors that can impact a final salary/hourly rate, including, but not limited to, Contract Wage Determination, relevant work experience, skills and competencies that align to the specified role, geographic location (For Remote Opportunities), education and certifications as well as Federal Government Contract Labor categories. In addition, MANTECH invests in its employees beyond just compensation. MANTECH’s benefits offerings include, dependent upon position, Health Insurance, Life Insurance, Paid Time Off, Holiday Pay, short-term and long-term Disability, Retirement and Savings, Learning and Development opportunities, wellness programs as well as other optional benefit elections. MANTECH considers all qualified applicants for employment without regard to disability or veteran status or any other status protected under any federal, state, or local law or regulation.