276 Clinical Data Jobs - Page 5

Frontera Health is revolutionizing pediatric healthcare by developing a cutting-edge, tech-enabled platform that delivers essential therapies to rural families. Our platform leverages AI/ML to create a robust video-based data model for early intervention and developmental disorders. By collaborating closely with parents, caregivers, and clinical partners, we re bridging the gap in access to care, improving health equity, and providing personalized treatment plans. Backed by leading investors like Lightspeed and Lux, Frontera Health is poised for rapid growth. Our ABA direct services are designed to meet the unique needs of children in underserved communities, providing them with the support and resources they require to reach their full potential. We are passionate about ensuring that every child, regardless of their location or socioeconomic status, has access to high-quality healthcare. By leveraging our technology platform and partnering with local providers, we are able to deliver effective ABA therapy to families who may otherwise have limited access to these essential services. Frontera Health is seeking a Clinical QA & Performance Lead to build and lead the quality systems behind our clinical annotation function. This team is responsible for labeling high-fidelity behavioral health data (video, audio, and text) that directly powers our AI models and clinical product insights. This role is equal parts quality architect, measurement analyst, and clinical systems thinker. You ll define what good looks like, build processes to track it, and ensure that the work we produce meets our clinical and scientific bar. You ll work closely with our Ops, ML, and Clinical teams to ensure that ambiguity is resolved quickly, feedback is integrated thoughtfully, and performance continuously improves. This is a hands-on leadership role with room to shape the future of clinical data quality at Frontera. What You ll Do Own definition and implementation of quality metrics (IOA / inter-rater agreement, audit scores, reviewer calibration) Build and maintain gold-standard datasets to serve as training and validation anchors Design QA workflows that balance precision, scale, and reviewer experience Lead reviewer onboarding and training systems, including calibration exercises and ongoing development Track performance across annotators and reviewers; flag drift and recommend coaching or retraining Partner closely with Ops Manager to align QA expectations with throughput goals Serve as a bridge between clinical subject matter experts, ML teams, and annotators to clarify labeling standards Monitor quality trends over time and drive continuous process improvement Facilitate periodic audits and synthesize findings into actionable recommendations What You ll Bring 4+ years experience in clinical QA, annotation QA, clinical operations, or healthcare analytics Familiarity with behavioral health, healthcare research, or human-annotated datasets Strong understanding of IOA/IRR concepts and metrics (e.g., Cohen s or Fleiss kappa) Experience building or managing QA systems in data labeling, research, or clinical settings Analytical mindset with comfort using tools to track trends, measure performance, and drive change Excellent communication and training skills able to support both junior annotators and senior stakeholders Thoughtful, systems-oriented approach to ambiguity, edge cases, and clinical nuance Bonus: Experience with tools like Label Studio or working in an ML-adjacent environment Why Frontera At Frontera, you ll be part of a mission-driven team using structured clinical data to reimagine pediatric therapy. Your work will directly shape the quality and reliability of the data behind our models and by extension, the care we deliver to families. Join us in building the future of developmental healthcare! We have determined a salary range for this position that takes into account several factors including experience, knowledge, education, skills, and abilities. Please note that the salary information is a general guideline and the exact salary will be determined based on the individual s qualifications and experience, with consideration given to the factors listed above. All full time employee benefits include a stake in shared success through stock options, health benefits, 401(k) plan, and responsible PTO. Expected salary range in Denver $110,000 $130,000 USD Frontera Health, Inc. is committed to creating and maintaining a diverse, equitable, and inclusive workplace where everyone feels valued, respected, and has the opportunity to thrive. We believe that our differences make us stronger and that all employees, regardless of their background, experiences, or abilities, contribute to our success. We are committed to: Providing equal employment opportunities to all qualified individuals, without regard to race, color, religion, sex, national origin, disability status, sexual orientation, gender identity or expression, age, genetic information, veteran status, or any other characteristic protected by law. Fostering a culture of inclusion and belonging where everyone feels valued and respected. Providing reasonable accommodations to employees with disabilities. Continuously learning and improving our DE&I practices. We will achieve this commitment by: Recruiting and hiring a diverse workforce that reflects the communities we serve. Creating and maintaining an inclusive work environment that is free from discrimination and harassment. Actively listening to and addressing the needs and concerns of all employees. We believe that diversity, equity, and inclusion are essential to our success as a company and to our mission of serving the pediatric behavioral health community. We are committed to continuous improvement in this area and welcome feedback from all employees.

Clinical Data Science Lead _ Office Based We are currently seeking a Clinical Data Science Lead to join our diverse and dynamic team. As a Clinical Data Science Lead at ICON, you will play a crucial role in driving data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions. You will contribute to the advancement of innovative therapies by overseeing data science projects and leading a team of data professionals. What You Will Be Doing: Leading the design and implementation of data science strategies to enhance clinical trial data analysis. Collaborating with cross-functional teams to identify key data requirements and analytical needs. Overseeing the development of statistical models and analytical tools to optimize data interpretation. Mentoring and guiding team members in best practices for data analysis and visualization. Communicating findings and insights to stakeholders through presentations and reports, influencing project direction. Your Profile: Advanced degree in statistics, data science, life sciences, or a related field. Extensive experience in data analysis and project leadership within a clinical research setting. Strong expertise in statistical software and data visualization techniques. Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights. Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams. 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

Clinical Data Science Lead _ Office Based 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 a Clinical Data Science Lead to join our diverse and dynamic team. As a Clinical Data Science Lead at ICON, you will play a crucial role in driving data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions. You will contribute to the advancement of innovative therapies by overseeing data science projects and leading a team of data professionals. What You Will Be Doing: Leading the design and implementation of data science strategies to enhance clinical trial data analysis. Collaborating with cross-functional teams to identify key data requirements and analytical needs. Overseeing the development of statistical models and analytical tools to optimize data interpretation. Mentoring and guiding team members in best practices for data analysis and visualization. Communicating findings and insights to stakeholders through presentations and reports, influencing project direction. Your Profile: Advanced degree in statistics, data science, life sciences, or a related field. Extensive experience in data analysis and project leadership within a clinical research setting. Strong expertise in statistical software and data visualization techniques. Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights. Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams. 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

The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for analysis datasets and provide QC done data packages including tables, figures, and listings for use in publications (ie, abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable; The Principal Biostatistician will ensure SOPs are followe'd, communications, timelines and quality metrics are met.; Collaboration of Local biostatistics and programming teams, Global Medical Affairs biostatisticians and / or programmers, and Global Medical Affairs Scientific Communications personnel. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs. 2) Support Sanofi Business Operations Leadership Team in understanding of stakeholders needs & expectations and provide end to end solutions for TAs/indications. 3) Coach/mentor new team members to support efficient and quick onboarding. 4) Support graduate hiring program as needed. Performance / Process: 1) Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (ie, Observational) data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages eg SAS. 3) Produce we'll documented data packages that include tables, listings, and figures. 4) Work closely with the Team Lead Biostatistician and/or Team Lead Programmer to develop and implement project QC plans, timelines and KPIs. 5) Learn, implement, and share through lecture series at least one indication of disease and product (Immunology, Multiple Sclerosis and Neurology, Rare Diseases, Rare Blood Disorders and Oncology) expertise. 6) Review appropriate biomedical and clinical research literature related to assigned project(s). 7) Active participation and Effective contributing in project governance meeting to proactively discuss risks, issues related to timelines and quality of deliverables. 8) Present your selected / assigned topic in lecture series internal and / or across line functions thereby improving the statistical knowledge and presentation skills. 9) Use Advanced analytical methods & tools to provide dashboards to the stakeholders. Customer: Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Masters degree 8 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology (preferred) and 4 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology Languages : Excellent English language knowledge written and spoken

Summary Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. These tasks are to be performed independently or team based with minimal guidance and supervision. About the Role 1. Produce and track reports for various line functions within Global Drug Development, used for ongoing monitoring of clinical data 2. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders 3. Author /co-author the user requirements document, functional specifications and functional testing scripts 4. Facilitate interaction with end-user on creating specifications and working with programmers or performing the programming activities for successful delivery. 5. To provide quantitative analytical support to the global program teams, including providing support on analyzing reports 6. Support the planning, execution and close-out of Clinical Programs/Trials. 7. Support the management in collation and delivery of analytics reports for critical decision making 8. Create, file and maintain appropriate documentation 9. Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program/trial operational data 10. Provide necessary training to end-user on best / appropriate and consistent use of various data review tools 11. Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R. 12. Good Knowledge of Novartis Clinical Data Standards and its implementation for creation of reports specifications or reports output 13. Support special projects of limited scope (sub team lead, local project, etc. ) both clinical and non-clinical in nature. 14. Provide study level expertise and involvement in CTTs. 15. Lead or provide support to special projects both clinical and non-clinical in nature or in general areas spanning various responsibilities but not limited to systems issues, processes, user support, training, etc. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Hiring: Team Lead Clinical Trials | Work from Office | Pune Location: Kothrud, Pune Shift: Evening / Night Job Type: Full-time (Work from Office) Salary: As per experience and best in industry Job Description: We are hiring for the position of Team Lead Clinical Trials . The role involves end-to-end management of clinical trial operations with a strong focus on quality, compliance, and timelines. The ideal candidate will lead cross-functional teams, manage client communication, and ensure the smooth execution of projects. Key Responsibilities: Lead teams including operations managers, team leads, quality analysts, and support staff. Monitor workflow and performance to identify and resolve issues. Provide mentorship and support to team members to promote a high-performance culture. Manage client onboarding, workflow planning, and quality assurance. Ensure compliance with industry regulations and client expectations. Present operational updates to senior management. Act as the primary contact for client communication and relationship management. Required Qualifications: Bachelors degree in Pharmacy or Life Sciences. 5 to 8+ years of experience in clinical research (BPO/KPO environment). At least 2 to 4+ years of experience in a leadership or team management role. Strong verbal and written communication skills. Excellent organizational and multitasking abilities. Work Environment: This is a Work from Office role based in Pune. Benefits: Competitive salary package. Health insurance and paid time off. Professional growth and learning opportunities. Only Walk-In Interviews Interested Candidates Can Contact: Sanjana 9251688426

Clinical Research Physician 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 Job Advert Posting At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. JOB FUNCTIONS/RESPONSIBILITIES: Serve as medical team leader on assigned projects, Ensure provision of all contracted activities and identification of out of scope activities on projects assigned Medical review of clinical trial data, including review of Laboratory alerts, Electrocardiogram (ECG) alerts, data from eCRF/ EDC (listing review/ Patient profile review), Eligibility review, Identify protocol deviations, coding review and preparation of Medical Monitoring Reports as per requirement Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: Medical information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing safety review of individual patient laboratory reports generated by central laboratories CRF safety review Contribute any necessary medical input into integrated clinical and statistical reports Assist in making presentations to potential clients when appropriate Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations Represent ICON Medical Affairs at teleconferences and meetings Liaise with Sponsors regarding medical issues and medical consultation Ensure quality of medical deliverables in accordance with project plans and ICON Standards Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention QUALIFICATIONS/EXPERIENCE REQUIRED: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Medical degree and broad based post graduate clinical experience Solid work experience in a relevant role, ability to medically evaluate clinical data, and good analytical skills Proficiency in English, Good oral and written communication skills Ability and willingness to travel on an as-need basis Excellent presentation skills Good computer skills (MS: Outlook, Word, Excel) Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. 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

Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance and mentorship to lower level and new staff. Essential Functions Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution. Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting. Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed. Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment. Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced. Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope. Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands scope of work and has an awareness of contract and budget assumptions. Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed. Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations. Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols. Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review. Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses. Clinical Study Report (CSR): Reviews or drafts CSR or statistical report. Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients. Lock and Unblinding Process: Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician. Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration. Qualifications Bachelors Degree Biostatistics or related field and 3 - 5 years relevant experience Req Or Masters Degree Biostatistics or related field and 3-5 years relevant experience Req Or Ph.D. Biostatistics or related field and 1 year relevant experience Req Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience. Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative. Strong organizing skills. Strong working knowledge of SAS computing package. Familiarity with other relevant statistical computing packages such as nQuery. Strong commitment to quality. Ability to effectively manage multiple tasks and projects. Ability to lead and co-ordinate small teams. Ability to solve moderately complex problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).

Job Overview Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance and mentorship to lower level and new staff. Essential Functions Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution. Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting. Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed. Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment. Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced. Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope. Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands scope of work and has an awareness of contract and budget assumptions. Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed. Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations. Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols. Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review. Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses. Clinical Study Report (CSR): Reviews or drafts CSR or statistical report. Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients. Lock and Unblinding Process: Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician. Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration. Qualifications Bachelors Degree Biostatistics or related field and 3 - 5 years relevant experience Req Or Masters Degree Biostatistics or related field and 3-5 years relevant experience Req Or Ph.D. Biostatistics or related field and 1 year relevant experience Req Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience. Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative. Strong organizing skills. Strong working knowledge of SAS computing package. Familiarity with other relevant statistical computing packages such as nQuery. Strong commitment to quality. Ability to effectively manage multiple tasks and projects. Ability to lead and co-ordinate small teams. Ability to solve moderately complex problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM). . 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

Summary #LI-Onsite #LI-Hybrid To provide operational support to Novartis Clinical operations team (stakeholders) with proper accounting of clinical expenses as per Novartis Standard/accounting policies/process, generate timely payment requests, track/monitor spends on clinical trials that are created using internal clinical data base About the Role Key Responsibilities: Provide operational partnership/ support to Novartis Clinical operations team (stakeholders) Proper accounting of clinical expenses as per Novartis Standard/accounting policies/process, generate timely payment requests, track/monitor spends on clinical trials that are created using internal clinical data base Partnering various stakeholders to ensure that, contractual terms in clinical trial agreements (CTA) reflects the protocol design; and reflected correctly on a Novartis Purchase Order. Liaison with various departments within Novartis to process investigator contract payments. Comply to various mandatory training . Demonstrate/comply Novartis value & behaviors and office etiquettes. Quick grasp on functional training related to job provided by Novartis during induction and ready to train new joiner in the team Provide accountable and transparent records for audit trail. Prior transition experience in any accounting process is preferred Generate various MIS reports; analyze investigators spend, forecasting, payment data and maintains historical information for both internal and external stakeholders. Business partner to ensure investigator spend compliance; analysis overdue & follow up to resolve queries/trouble shoot issues for all studies. Exposure to Lean Six Sigma methodologies for process improvements Essential Requirements: MBA or Master s degree in Finance from reputed institute or an equivalent accounting qualification 5+ years experience in finance/accounts payable in a leading multinational/ corporation Hands on Experience of working on SAP Macro s / Powerbi Should be a quick learner and able to train others Fluent English (oral and written Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Team Lead Statistical Programmer will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC d data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, and manuscripts); The Team Lead Statistical Programmer Provides leadership, guidance, and strategic inputs for all Sanofi Global Hub Programming personnel with different level of expertise through all projects of one or more TAs, and ensure their team members are current with advanced statistical programming techniques; The Team Lead Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Team Lead Statistical Programmer will ensure SOPs are followed and timelines and quality metrics are met; Secure delivery of high-quality of deliverables (TLFs) in time and in compliance with internal and external standards; Manage and ensure stakeholder s expectations ramping up programming teams and day to day operations to meet business requirements. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs. 2) Actively support to maintain interface between Medical Activities Hub and Stakeholder by facilitating regular interaction and implementing appropriate trackers. 3)Ensure continuous assistance to new team members to support efficient and quick onboarding and knowledge sharing sessions across Sanofi Global Hub. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Lead/contribute to the global coordination efforts to identify, develop, innovate/automate and implement departmental standards, applications, processes and trainings; participate to the evaluation of tools/applications and endorse their development. 3) Collaborate effectively with Principal biostatisticians and programmers to ensure high quality and timely statistical programming deliverables across the TAs. 4) Design, develop, test, implement, and document statistical programming in high-level software packages e.g., SAS. 5) Produce well documented data packages that include tables, listings, and figures. 6) Work closely with the Head Biostatistics and Statistical Programming, Principal Biostatisticians to develop and implement project management tools / tracker to automate the proper resource assignment & utilization, QC plans and timelines. 7) Develop and maintain statistical programming team using R / Python. Customer: Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. About you Experience : Masters degree minimum 8 years/B.Sc. minimum 10 years of relevant experience required Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and clinical data environment across multiple therapeutic areas Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge written and spoken Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com ! Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualification Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Qualification BSc,Master of Pharmacy

Clinical Research Physician Job Advert Posting At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. JOB FUNCTIONS/RESPONSIBILITIES: Serve as medical team leader on assigned projects, Ensure provision of all contracted activities and identification of out of scope activities on projects assigned Medical review of clinical trial data, including review of Laboratory alerts, Electrocardiogram (ECG) alerts, data from eCRF/ EDC (listing review/ Patient profile review), Eligibility review, Identify protocol deviations, coding review and preparation of Medical Monitoring Reports as per requirement Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: Medical information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing safety review of individual patient laboratory reports generated by central laboratories CRF safety review Contribute any necessary medical input into integrated clinical and statistical reports Assist in making presentations to potential clients when appropriate Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations Represent ICON Medical Affairs at teleconferences and meetings Liaise with Sponsors regarding medical issues and medical consultation Ensure quality of medical deliverables in accordance with project plans and ICON Standards Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention QUALIFICATIONS/EXPERIENCE REQUIRED: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Medical degree and broad based post graduate clinical experience Solid work experience in a relevant role, ability to medically evaluate clinical data, and good analytical skills Proficiency in English, Good oral and written communication skills Ability and willingness to travel on an as-need basis Excellent presentation skills Good computer skills (MS: Outlook, Word, Excel) Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. 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

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 39,000 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 The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is responsible for designing, programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager, Statistician and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. 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. Portfolio Delivery: Gather and influence eCOA design specifications from Clinical Trial Protocol to enable successful trial design and implementation As a Clinical database programmer, build, program and test Clinical trial data collection systems (eCOA database) and associated data repository mappings for a trial or set of trials within a program using data standards library components Ensure Clinical data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives Partner with translation vendors to implement localized data collection in country specific language Partner with Clinical Build Programmer to ensure complete data build for trial data collection needs Provide insights into study level deliverables (i.e., Data Management Plan, Project Plan, database, and observed datasets) Support submission, inspection and regulatory response activities Lead cross Business Unit/Therapeutic Area projects or programs with high complexity Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio Project Management: Increase speed, accuracy, and consistency in the development of systems solutions Enable metrics reporting of study development timelines and pre and postproduction changes to database Partner to deliver study database per business need and before first patient visit Follow and influence data standard decisions and strategies for a study and/or program Utilize therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making. Enterprise Leadership: Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis Represent Data and Analytics processes in multi-functional initiatives Actively engage in shared learning across Data and Analytics organization Work to Increase re-usability of screens and edits by improving the initial design Work to reduce postproduction changes change control process Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization Interacts with regulators, business partners and outside stakeholders on business issues Thinks with end to end in mind consistently managing risk to minimize impact on delivery Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development Focuses on defining database solutions and timelines in support of advancing the portfolio Basic Qualifications & Requirements: Bachelor s or Master s degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, Information Technology, with hands-on experience in database programming, or a combination of clinical data management, system validation and data analysis, experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors. Working experience in eCOA (electronic Clinical Outcome Assessment) or eDC (electronic data capture), eSource or Direct Data Capture implementation Design of electronic CRF screens to capture Clinical data and build on required validations Understanding of Clinical Protocol and interpretation of the Clinical terminologies to create or design specifications Familiarity with Clinical data tools, technologies, workflow for collecting patient data, testing and validation of system Analyse the impact and implement post production changes the Study design Data analytics and visualizations Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions Deciding the technology platform (system/database) for data acquisition and aggregation Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e., Data Sciences, Statistics, PK, Operations, Medical) Strong therapeutic/scientific knowledge in the field of research Project management experience Vendor management experience Understanding and experience in using data standards Knowledge of medical terminology Ability to balance multiple activities, prioritize and manage ambiguity Demonstrated exemplary teamwork/interpersonal skills Proven problem solving, attention to detail and result oriented behaviors in a fast-paced environment. Additional Preferences: Programming experience with HTML, CSS, JAVASCRIPT, Node.js, JSON. Experience with relational and non-relational database technologies utilizing SQL, Data Functions and Procedures. Technical proficiency with HTML, Data Mapping, understanding of database structures, etc. Experience handling GITLAB utilities Quick learner to new trends in technology Excellent leadership, communication (written and oral) and interpersonal skills Demonstrated leadership in professional setting Demonstrated teamwork and collaboration in a professional setting Other Information: Domestic and International travel may be required . .

Contributing as a product expert, analyzing and translating business needs into long-term solution data models. Evaluating existing data systems and working with the development team to create conceptual data models and data flows. Understands what is out of the box vs. configuration vs. customization of base software product platforms, as well as performance, scalability, and usability considerations. Develop and maintain data ingestion, data analysis, and reporting solutions for Clinical data Collaborate with cross-functional teams to identify and solve complex data-related problems Develop and maintain documentation, processes, and workflows related to Clinical data review process Troubleshoot and debug issues related to data ingestion, analysis, and reporting Serve as subject matter expert and keep up-to-date with new technologies and industry trends Experience and Skills Experienced and familiarity with data ingestion and processing capabilities Ability to utilize design thinking to perform prototyping and architecture definition of extraction transformation and loading (ETL) processing. Expert level programming capability (Python and PL/SQL, SAS) or ability to read/interpret code and engage expert programmer. Frameworks/Libraries: Pandas, Numpy |Version Control: GitHub Experienced in working in in GCP and regulated data space. Candidate must carry excellent communication, analytical and interpersonal skills. Knowledge of Data Science is a plus. 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 Save this job LEARN ABOUT HOW WE WORK Join our Global Talent Network Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

Python Programmer (G140/150) Key Responsibilities Contributing as a product expert, analyzing and translating business needs into long-term solution data models. Evaluating existing data systems and working with the development team to create conceptual data models and data flows. Understands what is out of the box vs. configuration vs. customization of base software product platforms, as well as performance, scalability, and usability considerations. Develop and maintain data ingestion, data analysis, and reporting solutions for Clinical data Collaborate with cross-functional teams to identify and solve complex data-related problems Develop and maintain documentation, processes, and workflows related to Clinical data review process Troubleshoot and debug issues related to data ingestion, analysis, and reporting Serve as subject matter expert and keep up-to-date with new technologies and industry trends Experience and Skills Experienced and familiarity with data ingestion and processing capabilities Ability to utilize design thinking to perform prototyping and architecture definition of extraction transformation and loading (ETL) processing. Expert level programming capability (Python and PL/SQL, SAS) or ability to read/interpret code and engage expert programmer. Frameworks/Libraries: Pandas, Numpy |Version Control: GitHub Experienced in working in in GCP and regulated data space. Candidate must carry excellent communication, analytical and interpersonal skills. Knowledge of Data Science is a plus. . 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

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams. If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Python Programmer (G140/150) Key Responsibilities Contributing as a product expert, analyzing and translating business needs into long-term solution data models. Evaluating existing data systems and working with the development team to create conceptual data models and data flows. Understands what is out of the box vs. configuration vs. customization of base software product platforms, as well as performance, scalability, and usability considerations. Develop and maintain data ingestion, data analysis, and reporting solutions for Clinical data Collaborate with cross-functional teams to identify and solve complex data-related problems Develop and maintain documentation, processes, and workflows related to Clinical data review process Troubleshoot and debug issues related to data ingestion, analysis, and reporting Serve as subject matter expert and keep up-to-date with new technologies and industry trends Experience and Skills Experienced and familiarity with data ingestion and processing capabilities Ability to utilize design thinking to perform prototyping and architecture definition of extraction transformation and loading (ETL) processing. Expert level programming capability (Python and PL/SQL, SAS) or ability to read/interpret code and engage expert programmer. Frameworks/Libraries: Pandas, Numpy |Version Control: GitHub Experienced in working in in GCP and regulated data space. Candidate must carry excellent communication, analytical and interpersonal skills. Knowledge of Data Science is a plus.

Project Technical support - III- ICMR ICRAG-2 Project Division Non Division User Contact Person Ms. Lincy Thomas Job Details Brief Description about the Project A Multicentre multi-method study for development and Validation of a Deprescribing Tool, followed by Implementation and evaluation of its impact, facilitators and barriers. The study will be done in three main steps 1. Formative research using Systematic/Rapid Review, Mixed methods study and a qualitative study. The intervention components will be then prioritized using Delphi process and will be locally customised. 2. The IP will be evaluated through a cluster RCT for effectiveness, implementation research outcomes and cost effectiveness. 3. In this step, we will disseminate the findings and learnings of the study through symposia s and we will conduct effective policy dialogues with key stakeholders. Project Technical support - III No. of Vacancy: One Preferred Qualifications: 1. Three years Graduate in relevant subject / field + three years experience or PG in relevant subject / field 2. For Engineering / IT /CS first class four years Graduate Degree + Three years Experience Maximum Age Limit : 35 years Salary: Rs.36,400 /- per month Language : Good communication in English Experience: Two to three years experience in a recognized institute/hospital Knowledge of Computer Applications Experience in prescription data collection/analysis or research project Experience in Clinical data collection, including interviews/surveys Last Day for Receiving Application: 7th July 2025 Location: Bangalore Roles and Responsibilities: Overall coordinate the study; closely work with the Project Scientist and investigators. The Principal Investigator ICMR ICRAG-2 Project

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Job Purpose: Maintains record of patient care by compilingreviewingand filing documentation of patients conditiontreatmentand health outcome. Job Responsibilities: Maintains medical records operations by following policies and procedures; reporting needed changes. Initiates medical record by searching master patient index; identifying existing patient records or need to assign a new number; interacting with registration areas and physicians offices for information verification; processing or creating the record folder. Ensures medical record availability by routing records to admissions and emergency departmentsphysiciansand other authorized hospital staff; maintaining chart location systems. Completes medical record by reviewing information; notifying health care providers of record deficiencies; tracking outstanding records; notifying medical director of physicians in jeopardy of losing admitting privileges. Maintains historical reference by abstracting and coding clinical datasuch as diseasesoperationsproceduresand therapiesusing standard classification systems; filing documents. Provides medical record information by answering questions and requests of patientshospital stafflaw firmsinsurance companiesand government agencies. Maintains patient confidence and protects hospital operations by keeping information confidential; following release-of-information protocols. Maintains the stability and reputation of the hospital by complying with legal requirements. Keeps equipment operational by following manufacturers instructions and established procedures. Conserves resources by using equipment and supplies as needed to accomplish job results. Contributes to team effort by accomplishing related results as needed. Candidate Requirements: Time Management Attention to Detail Quality Focus & Productivity Documentation Skills - Written Communication Data Entry Management Equipment Maintenance Supply Management Ability to plan & organize ones work schedule effectively.

The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is responsible for designing, programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager, Statistician and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. 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. Portfolio Delivery: Gather and influence eCOA design specifications to enable successful trial implementation Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives Partner with translation vendors to implement localized data collection Partner with Clinical Build Programmer to ensure complete data build for trial data collection needs Provide insights into study level deliverables (ie, Data Management Plan, Project Plan, database, and observed datasets) Support submission, inspection and regulatory response activities Lead cross Business Unit/Therapeutic Area projects or programs with high complexity Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio Project Management: Increase speed, accuracy, and consistency in the development of systems solutions Enable metrics reporting of study development timelines and pre and postproduction changes to database Partner to deliver study database per business need and before first patient visit Follow and influence data standard decisions and strategies for a study and/or program Utilize therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc) to study build deliverables Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making. Enterprise Leadership: Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis Represent Data and Analytics processes in multi-functional initiatives Actively engage in shared learning across Data and Analytics organization Work to Increase re-usability of screens and edits by improving the initial design Work to reduce postproduction changes change control process Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization Interacts with regulators, business partners and outside stakeholders on business issues Thinks with end to end in mind consistently managing risk to minimize impact on delivery Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development Focuses on defining database solutions and timelines in support of advancing the portfolio Basic Qualifications & Requirements: bachelors or masters degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, Information Technology, with hands-on experience in database programming, or a combination of clinical data management, system validation and data analysis, experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors. eCOA (electronic Clinical Outcome Assessment) or eDC (electronic data capture), eSource or Direct Data Capture implementation Design of electronic CRF screens to capture Clinical data and build on required validations Understanding of Clinical Protocol and interpretation of the Clinical terminologies to create or design specifications Familiarity with Clinical data tools, technologies, workflow for collecting patient data, testing and validation of system Analyse the impact and implement post production changes the Study design Data analytics and visualizations Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions Deciding the technology platform (system/database) for data acquisition and aggregation Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (ie, Data Sciences, Statistics, PK, Operations, Medical) Strong therapeutic/scientific knowledge in the field of research Project management experience Vendor management experience Understanding and experience in using data standards Knowledge of medical terminology Ability to balance multiple activities, prioritize and manage ambiguity Demonstrated exemplary teamwork/interpersonal skills Proven problem solving, attention to detail and result oriented behaviors in a fast-paced environment. Additional Preferences: Programming experience with HTML, CSS, JAVASCRIPT, Node.js, JSON. Experience with relational and non-relational database technologies utilizing SQL, Data Functions and Procedures. (e.g., MongoDB) Technical proficiency with HTML, Data Mapping, understanding of database structures, etc Experience handling GITLAB utilities Quick learner to new trends in technology Excellent leadership, communication (written and oral) and interpersonal skills Demonstrated leadership in professional setting Demonstrated teamwork and collaboration in a professional setting Other Information: Domestic and International travel may be required

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Duties/Responsibilities Lead/actively participate in departmental and/or cross-functional initiatives geared towards updated technological solutions, process improvements, standards and governance updates etc. and regularly disseminate information to teams and stakeholders. Drive forward a lean SDTM implementation group capable of delivering quality SDTM data early in a clinical trial with innovative transformation solutions. Keep abreast of CDISC industry standards and participate in industry wide technical discussions via conferences and webinars. Represent SDTM programming during internal audits as needed. Managerial Responsibilities: Develop job descriptions and career paths for programmers and effectively forecast resource needs, recruit, manage, develop, evaluate, reward, motivate and retain direct reports, resulting in an increasing level of capabilities within GBDS. Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies. Aligns objectives, feedback and performance evaluation with direct manager. Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback. Holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with Head of Clinical Data Strategy, Systems, Reporting and Analytics regarding promotions, performance concerns, and retention risks. Build inter-departmental relationships and resolve issues as needed. Qualifications Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred. Minimum of 10 years clinical/statistical programming experience within pharmaceutical clinical development. Minimum 5 years of experience in managing technical professionals in a regulated environment. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: