: Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions: Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e. g. , coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. " Qualifications: Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Work closely with analysts / moderators to ensure transcripts, highlights, key questions and summaries reflect the quality standards and deliver to the clients actionable content without any personal bias the views of the subject-matter experts Monitor and generate reports to make sure transcripts, highlights, key questions and summaries are delivered on-time In collaboration with analysts / moderators develop survey questions, review submitted responses from the experts, develop slides to capture the takeaways from surveys What You Have: Masters s degree or Preferably PhD in life sciences preferred with 2+ years experience in Medical Writing, and clinical data analysis Working knowledge of AP writing styles; experience following in-house guideline Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and/or clinical data Computer skills including but not limited to Microsoft Office or equivalent suites, CRM and/or CMS systems, and business communication and collaboration platforms Proven ability to excel in fast-paced, deadline-driven environments Excellent communication skills, meticulous attention to detail, and a positive attitude

Working with Us 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 rich in diversity Take your career farther than you thought possible 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 At Bristol Myers Squibb, we are inspired by a single vision transforming patients' lives through science In oncology, hematology, cell therapy, immunology, cardiovascular and neuroscience disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change We bring a human touch to every treatment we pioneer Join us and make a difference Position Summary Manager 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 Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e g , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 5 years programming experience in industry recommended Experience in reporting for Clinical Pharmacology studies is preferred Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs Have in-depth understanding of clinical data structure (e g CDISC standards) and relational database Demonstrated skills in using software tools and applications, e g , MS office, XML, Pinnacle 21 Demonstrated ability in the handling and processing of upstream data, e g , multiple data forms, workflow, eDC, SDTM Demonstrated ability in providing outputs to meet downstream requirements, e g , ADaM, Data Definition Table, e-submission Have good understanding of regulatory, industry, and technology standards and requirements Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs Demonstrated ability to work in a team environment with clinical team members 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 Uniquely Interesting Work, Life-changing Careers 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 On-site Protocol Responsibilities BMS has a diverse 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: 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

Working with Us 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 rich in diversity Take your career farther than you thought possible 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 Data Review Responsibilities will include, but are not limited to: Understand and review Protocol along with relevant data review documents (e g Protocol Data Review Plan, Data Quality Management Plan) Review clinical data listings Manage and facilitate resolution of data discrepancies Perform data cleaning as per the defined Clean Patient Group Freezing & Locking of CRFs/Fields Coordinate with Data Management Lead for study deliverables External Data: complete review of loaded external data Track data load and address discrepancies Coordinate with external data vendor for resolution of data discrepancies as applicable Documentation: Filing of appropriate documents in eTMF as per eTMF master plan Bachelor's Degree required Life sciences, Pharmacy or relevant fields preferred 2 years of experience in Clinical Data Review tasks Able to work on clinical data review tasks Able to work collaboratively on multi-disciplinary project teams Basic knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Good knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills Good oral and written communication skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) 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 Uniquely Interesting Work, Life-changing Careers 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 On-site Protocol Responsibilities BMS has a diverse 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: 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

Skill required: Clinical Data Services - Medical Monitoring Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years 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 world's 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.Provides medical expertise for trial oversight and safety concerns. This includes creation, review and validation of protocol requirement specifications as per the applicable SOP. What are we looking for? Ability to work well in a team Adaptable and flexible Strong analytical skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BTech,Bachelor of Pharmacy,Master of Pharmacy

PRODUCTLIFE Group is looking for Medical Advisor VAF 173 to join our dynamic team and embark on a rewarding career journey. Medical Advisor VAF 173 is responsible for overseeing and optimizing medical advisor vaf 173 operations. This role involves strategic planning, team coordination, and execution of tasks to ensure efficiency and productivity. The incumbent will collaborate with stakeholders to align operations with business goals. Duties include monitoring performance, ensuring compliance with policies, and implementing best practices. Additionally, they will manage resources, resolve operational challenges, and contribute to continuous improvement initiatives. Strong analytical skills, leadership abilities, and industry knowledge are essential for success in this role.

The Position As a Medical Writer you will ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Furthermore, you will communicate across the time zones and in different professional environments. This job requires good communication and analytical skills. In order to meet timelines, you must be good at planning own work and be proactive when problems arise and seek help and advice from relevant people within GBS as well as within Head Quarters (HQ). Additionally, you will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved. You are entrusted to fulfil the following responsibilities: You will be performing medical writing tasks for trial and/or non-trial activities within clinical reporting including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Layperson Summary (LPS), Investigator Brochure (IB) and Regulatory response documents (Q&A). You will have to communicate the clinical data in a clear and concise manner. You will contribute to knowledge sharing and maintain good relationship with the stakeholders and colleagues. Qualification You are expected to have the below skills and knowledge: Graduate (PhD, MSc., M Pharm, Pharm D, or equivalent). 2+ years of experience as medical writer or other relevant work experience. Experience working within a global setting.Experience from the pharmaceutical /CRO industry. Strong understanding of external requirements related to regulatory documents. Good communication skills. Works independently on smaller tasks. Strong analytical skills. Committed, persistent and accountable. Able to plan and manage variable workload.

You are an excellent communicator with strong Clinical research expertise .You will work with the quality management tools in our Electronic Health Record service, athenaClinicals, to support client participation on pay-for-performance and pay-for-value initiatives. You should be able to strive in both independent and team environments and be comfortable communicating between the business and development teams. The Team: A quality program (or Clinical Quality Improvement program) is a collection of healthcare quality measures/metrics grouped together and applied for a meaningful purpose, to evaluate and/or incentivize an entity to improve clinical and/or financial outcomes. These entities are typically providers, provider groups (IPAs, PHOs, ACOs), and payers. The main purpose of a healthcare quality program is to assess performance as it relates to controlling costs, and to create an environment that incentivizes participants to adhere to the quality standards. Job Responsibilities Develop knowledge on quality improvement trends in the healthcare industry, sharing this knowledge with multiple stakeholders Learn the Quality Management tools, workflows and reporting capabilities of our Electronic Health Record, athena Clinicals Understand, assist with inputs to develop and implement QM analysis and reporting processes, tools and metrics Typical Qualifications Bachelor s degree, PA, NP, MBA, MPH or MS preferred Minimum 3 + years professional experience, healthcare experience preferred Work experience with athenaNet Preferred Work hours are 1 to 10pm IST About athenahealth Here s our v ision: To create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all. What s unique about our locations From an historic, 19 th century arsenal to a converted, landmark power plant, all of athenahealth s offices were carefully chosen to represent our innovative spirit and promote the most positive and productive work environment for our teams. Our 10 offices across the United States and India plus numerous remote employees all work to modernize the healthcare experience, together.

In this role you will act as an advisor within the Clinical Data Operations team, providing guidance to challenge and improve global business processes, products, services, and software through data analysis. You will engage with global business leaders and leverage the appropriate Data Digital and IT (DDIT) teams and Functions to determine requirements and deliver data driven recommendations to improve efficiency and add value. Job Description Role Responsibilities: Collaborate with the Clinical Data Ops team under Global Clinical Operations IT, including technical leads, business partners, and other business analysts. Partner with the business to shape technology solutions and ensure alignment with the business technology strategy. Manage and deliver projects such as SAAS implementation, home-grown solution development, data review solutions, and automation work. Act as an advisor to improve global business processes, products, services, and software through data analysis. Ensure consistency and traceability between user requirements, functional specifications, and testing and validation. Support validation and testing as appropriate and ensure adherence to Security and Compliance policies and procedures within Service Delivery scope. Role Requirements: Worked in prior Business Analysis role for minimum of 10+ years in large matrixed organization. Strong stakeholder management, collaboration skills as well as an adaptable communication style Experienced in understanding business and domain terms and language and translate them into requirements. Proven ability to challenge and improve local/simple business processes, products, services, and software through data analysis. Experienced in delivering data driven recommendations to improve efficiency and add value Preferred: Expertise with 5+ years experience in Pharma R&D Development knowledge of Business Processes. Experienced with 5+ years in Clinical Data Management and workflows

Key Responsibilities: Prepare and write high-quality scientific content, ensuring compliance with industry standards and company SOPs. Curate scientific content with proper formatting and clarity, ensuring the accurate representation of scientific and clinical data while maintaining plagiarism-free writing. Stay updated with industry trends, regulatory changes, guideline updates, and recent medical literature to optimize content quality and incorporate clinically relevant updates. Manage timelines and deliverables effectively, ensuring content quality is not compromised. Develop surveys, polls, and quizzes across various specialties based on recent updates in clinical practice. Preferred Qualifications: M.Sc. or Ph.D. in Life Sciences, or a background in B. Pharm / M. Pharm. Proven experience in medical writing within the pharmaceutical or healthcare industry. In-depth understanding of the subject matter and scientific principles. Proficiency in using Microsoft Office Suite. Strong ability to manage multiple projects, meet deadlines, and maintain high-quality standards.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years 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, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The clinical automation team focuses on the development and implementation of innovative concepts and application for our client across different accounts in operations. The team is responsible for designing and implementing highly interactive scalable web apps and prototypes at enterprise level.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, Python, Full- Stack Developer. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team Bachelor's degree in Computer Science, Information Technology, Engineering or any computer related discipline. Work experience of at least 3 year in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.). Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions. Work experience in Implementing APIs based architecture frameworks. Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment. Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations. Design and implement highly interactive, scalable web apps and prototypes at Enterprise level. Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly. Implement APIs based on architecture frameworks and guidelines. Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines. Able to lead Automation initiatives within his account. Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution. Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain. Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust. You should be able to pilot and deploy automation solutions at scale. Partner with the testing team to ensure applications/components are fully functional. Oversee and fix any defects or performance problems discovered in testing. Participating in analyses of requirements as well as functional design whenever necessary. Be involved in the design of the solution. Performing design, coding, application maintenance and testing activities. Take ownership of the successful implementation of the solution. Qualifications BE,BTech,MCA

What we do At Founda, were driven by a deep curiosity about the future of healthcare. Our mission is to build the global infrastructure that empowers innovators to shape tomorrows healthcare system. Founda Health is at the forefront of healthcare innovation, redefining how clinical data moves between systems. We are passionate in enabling change, dedicated to overcoming healthcares connectivity hurdles and ensuring seamless data exchange between electronic healthcare systems and cutting-edge digital health solutions. We aim to free healthcare professionals and digital health companies from administrative burdens, allowing them to prioritize patient care above all else. As a Senior Software Engineer, your role will be instrumental in advancing healthcare interoperability. Were currently developing a self-service global infrastructure designed to facilitate seamless, secure, and compliant data exchange between data providers (such as care providers) and data consumers (including applications, lab systems, IoT devices, and other care providers). Our mission extends to a global scale, presenting an array of challenges due to diverse healthcare processes, diverse electronic health record (EHR) implementations, unique terminologies, fragmented data (standards), and varying regulations. Things you could be working on: Build a pre-fetch service that ensures medical images are available on the local PACS device when needed Build a Metrics API that aggregates, stores and exposes tens of millions of data points from different sources that provide insights to our customers Build world class developer experience for our platforms. Work on a data normalisation and terminology layer that ensures a uniform gateway experience independent of the EHR system that is interacted with. Expand our interaction patterns by adding new functional flows in a standardized way. Rewrite a performance heavy service from Java to golang. In our engineering team: We value teamwork and collaborate to tackle complex problems. We actively contribute to the roadmap. We perform code reviews and test our work. These activities are integral to our daily workflow. We prioritize quality over quantity. We all have the ability to push code to production; ownership is a core value. We can contribute across the entire codebase, ensuring a collaborative and inclusive environment. We have engineering leadership that has a technical background. We provide mentorship and guidance. We are committed to your individual growth and invest in your professional development. We work on projects that positively impact the world every day. We have a remote first culture, but like to meet once a week in our clubhouse. Our Technology Stack Back-end: Java, Golang, Python, Postgres, Redpanda, Redis, Pact. Front-end: Vue 3, Typescript, Nuxt, Vite, Pinia, Antdv, Pact, Playwright. Infrastructure: Kubernetes, Terraform, AWS. Tooling: Gitlab, Elastic, Prometheus, Alert manager, Github co-pilot, Unleash, Sentry, ArgoCD, Linear. Working methodology: Shape up. Our Ideal Candidate Demonstrates a versatile engineering skill set, contributing to various parts of the platform; a true Polyglot engineer. Is comfortable working with two or more of the following languages: TypeScript, Golang, Python, or Java(mandatory). Brings multiple years of production experience with event-driven (micro)services in a scaling environment. Advocates for a strong engineering culture and cloud native thinking. Actively supports its continuous improvement. Possesses a proactive "can-do and can-learn" mindset. Has the ambition to grow to a staff level position and understands what it takes to get there. The Recruitment Process Introductory call - with our People Partner. We look forward to getting to know you and tell you all about Founda. Team Introduction Call - with two of your future peer engineers. Technical Case - Deep-Dive Session - with two of your future peer engineers. A technical conversation covering a wide range of topics focused on our technical stack. Conversation with our Engineering Managers: A final conversation to talk about company goals, your ambitions and shared expectations. Our offer. Including all the time and space you need to ask any questions. Our people team is ready to support you in this final step. Why choose Founda health: Attractive salary. Work with purpose, meaning ownership. Work-from-home budgets to set up your home office. A minimum of 25 holidays a year, with the flexibility to take more if needed. Extended maternity and paternity leave policies. Fun Social events to relax and connect with each other. Join Us in Our Mission We aspire to become the leading platform for data exchange within the global healthcare landscape. Its an ambitious and challenging goal, and we invite you to join us on this exciting journey. We understand that ideal candidates may not fit every requirement perfectly, and we encourage you to apply if the main qualifications align with your skills and experience. Research has shown that many candidates hesitate to apply unless they meet all requirements listed in job ads. At our company, we value diverse perspectives and experiences, and we welcome applicants from all backgrounds. If youre excited about our mission and believe you can contribute to our team, we would love to hear from you!

Are you passionate about delivering high-quality solutions design consultation to pharmaceutical and biotechnology clients Clario is looking for a dedicated Team Lead to join our eCOA Solutions Design team in India. In this role, you will work closely with project teams and interface with clients and Clario solutions delivery leadership to ensure clinical protocols are efficiently and accurately mapped to software solutions within project scope. As a Team Lead, you will serve as an escalation point for study-related issues, assist in project allocations, utilization, and productivity, and take on supervisory responsibilities. If you thrive in a collaborative environment and are committed to excellence, we want to hear from you! What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Support the performance review process by providing applicable feedback to Solutions Design management, Conducts one on one bi-weekly meetings with Solutions Design Analyst team to discuss project status, issues, and issue resolution strategies Formally summarizes and responds to audit observations, and ensure implementation of any Corrective and Preventative Actions Functions as a subject matter expert to advise on internal devices and system functionalities, acting as a resource and mentor for other SD team members Functions as a subject matter expert to advise internal and external clients on design processes, specification design, and requirement gathering best practices Serves as escalation point on Study Related Issues Coordinates the overall Solutions Design Process ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately and within project scope Creates and maintains specifications for study-specific implementations of Clario products and services using a Documentation Management System Ensures consistency between trial data capture, data delivery and database structures to meet client requirements Is responsible for the overall management of the Design Process including communication of design requirements internally and externally with the Customer. This includes participation in internal and external design milestone meetings Collaborates with Clinical Systems Translation Licensing (CSTL) to confirm correct versions of copyrighted questionnaires are implemented Supports Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner Collaborates with other departments to investigate study issues found beyond the start-up phase of the study Collaborates with DM to ensure that the software solution captures the necessary data points for data extraction and that the Data Management Plan supports the software solution Assists in project scoping and change control processes including revision management Provides Estimates on new product initiatives, Assists in the evaluation of new product features Provides feedback with regard to product functionality and shares with Product Development group. Collaborates with RD, Design, Innovation (design custom controls) Contributes to developing new core product offerings, and advising on improving existing devices Provides input to interdepartmental process improvement initiatives Coordinates the training of new team members on all aspects of the design process and standard practices and ensures these practices are consistently implemented across the group Performs Process Evaluation and leads internal projects to develop best practices Assists and advises on process Documentation, SOP, and Work Instructions related to departmental deliverables Tracks and evaluates trends in issues, CAPAs and project health to advise training topics Assists/Supports in the training of the SD staff on standard practices and ensures these practices are consistently implemented across the group Supports Solutions Design Delegate in audit preparation by researching project specific or process standards information as needed to evaluate or respond to audit findings Manages Solutions Design project allocations and resource assignments, utilization and productivity Assists management in monitoring and ensuring that design milestones are met on time across the department Reviews and analyzes proposals and protocols as needed, oversee and approve new study quotations Assists in the coordination of project allocations, utilization, productivity, and approval of timecards Completes activities in the Training Management System in a timely manner Tracks time for billable study related and non billable tasks in a timely manner Tracks SDA milestone start and completion dates using the Clario project scheduling tool Represents Solutions Design in sales inquiries describing the design function and best practices Collaborates with senior leadership counterparts from other Departments Serves as additional delegate representing Solutions Design in client audits to describe process flows, standards and best practices Assists management conduct interviews for hiring SDAs Leads internal SD team meetings as needed Participates in bid defense preparations when required May perform the role of Squad Leader of a cross functional team within Solutions Delivery made up of 12-15 employees working on assigned studies. Coordinates the solutions development process among team members ensuring that customer commitments, timelines and quality standards are met Collaborates with Sales and Science teams to act as a Subject Matter Expert on Devices, Device Functionality, Study Designs and Modalities to support new study quotations where appropriate Performs other duties as directed by Solutions Design Management What were looking for BS, BA or equivalent (in science/health care-related field a plus) Previous experience working with with eCOA / ePRO, IRT/RTSM, eConsent, or other eClinical / Clinical / Healthcare technology solutions is highly desirable Minimum of 8 years of total relevant experience Minimum of 5 years of Clinical Indication Specific experience Minimum of 3 years of Sponsor Specific Standards experience Demonstrated ability to mentor and lead a team Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models Demonstrated experience in interpretation of client requirements to prepare and document design specifications Proven experience in client relations and interactions with clients at all levels Familiarity with FDA regulatory processes, clinical research processes Self directed - comfortable working in a fast-paced environment Ability to manage multiple project tasks and deliverables Proven problem-solving skills and attention to detail Excellent presentation, communication (written and oral) and negotiation skills At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

The purpose of the Statistical Analyst role is to develop or assist in the development of experimental design, validation and optimization, and provides analysis support for scientists in non-clinical research (Discovery and Development). The job tasks listed below outline the scope of the position. The application of these tasks may vary based upon current business needs. Statistical Design and Analysis Implement analysis applications per customer needs. Collaborate on development of tools for customers. Conduct data analysis under the guidance and supervision of experienced statisticians. QC biomarker data from research lab, extract/clean clinical data from Lilly clinical trials for proper biomarker data analysis. Create tables, figures and reports to effectively communicate study findings. Implement statistical analysis methods and develop automated data processing and analysis tools to streamline/speed up workflows. Review and validate data analysis and reports. Lead effort to appropriately incorporate data mining, machine learning, or other methodologies (tools, strategies, validation, etc.). Communication of Results Collaborate with team members or external partners to communicate results. Assist with or be responsible for communicating study results via manuscripts or oral presentations. Communicate results in one-on-one meetings with key customers or external partners and present at scientific and therapeutically focused meetings. Therapeutic/Scientific Area Knowledge Understand disease states or scientific areas in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, local, and departmental policies, procedures, processes, and training. Statistical leadership and Teamwork Introduce and apply innovative methodology and tools to solve critical problems. Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions. Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions. Minimum Qualification Requirements: M.S., Ph.D., or equivalent experience Statistics, Biostatistics field study, Data Science or equivalent Having 5 years of experience in R and/or SAS programming. Clinical data experience will be an added benefit Other Information/Additional Preferences: Proficient in a statistical programming language Interpersonal/teamwork and communications skills for effective customer consultation Strong teamwork and leadership skills Technical growth and application with working knowledge of experimental design and statistics Self-management skills, creativity and innovation. Resource management skills Demonstrated problem solving ability and strategic thinking.

Regional Medical Advisor THE OPPORTUNITY The RMA (Regional Medical advisor) will be a valued representative at our company working in the field to interact and engage key stakeholders. Our medical affairs team objective is to provide scientific expertise across their identified regions/products/therapy areas to these valued customers. WHAT YOU WILL DO: The RMA will have the following key responsibilities: Developing and implementing medical strategies: Scientific leader identification development and engagement to build regional, national or international relationships to contribute to understanding of diseases, scientific trends, practice guidelines, and treatment patterns in areas relevant to our business Support to the health care providers by providing accurate and up-to-date medical information Education, training and periodic medical updates to the commercial team as demanded Ensuring compliance with local regulations and industry standards in all medical activities Responsibilities and Primary Activities: Scientific Expertise: Developing and maintaining an in-depth understanding of the companys products, therapeutic areas, and relevant scientific research. Staying updated on the latest medical and scientific advancements, clinical guidelines, and treatment protocols. SL KDM Engagement: Building and maintaining relationships with Scientific Leaders (SLs), Key decision makers (KDMs) healthcare professionals, and academic institutions. Engaging in scientific discussions, presenting clinical data, and providing educational support to KOLs regarding the companys products and therapeutic areas. Support to medical strategy: In alignment with the line manager, provide strategic inputs, and expertise, to product management towards ethical promotion of assigned products Medical Education: Providing scientific and medical education to internal stakeholders, including sales teams, marketing teams, and other cross-functional colleagues. Collaborating with the Medical Affairs team to develop and deliver training materials, presentations, and scientific symposia. Scientific Exchange: Facilitating scientific exchange and knowledge transfer between the company and external stakeholders. Participating in medical conferences, advisory boards, and scientific meetings to gather insights, share data, and contribute to the scientific community. Clinical Data Communication: Interpreting and communicating clinical trial data, real-world evidence, and other scientific information to healthcare professionals, regulators, and other relevant stakeholders. Ensuring accurate and compliant dissemination of scientific information in accordance with regulations and company policies. Clinical Research: Provide medical support for local studies, including need-based visits to identify study sites Lead Investigator Initiated Trials Cross-functional Collaboration: Collaborating closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Marketing, and Market Access, to provide scientific input, support clinical trial design, contribute to regulatory strategies, and align on medical communication plans. Facilitate access to scientific leaders as appropriate. Support as well as own medical initiated projects in line with therapy area that would involve a strong stakeholder interface Provide scientific support to sales team Medical Information: Addressing medical inquiries and providing timely and accurate responses to healthcare professionals, patients, and other stakeholders. Ensuring that medical information materials, such as medical letters and FAQs, are up to date and compliant. Sales Force Training: Provide medical training to sales colleagues on the therapy areas assigned Assist in pre-launch and launch training to sales staff for new products. Compliance: Adhering to relevant legal, regulatory, and compliance guidelines, including the organizations code of conduct and industry-specific regulations. Ensuring all activities and interactions are conducted ethically and in compliance with applicable laws and regulations. Overall, RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviors: Consistently adhere to/demonstrate all company Values with focus on excellence Work in harmony with internal and external stakeholders WHAT YOU MUST HAVE To be successful in this role, you will have strong marketing skills as well as business capabilities Educational Background: A strong academic background in life sciences, such as a medical degree (MD), doctorate (Ph.D.). Other relevant degrees in biology, pharmacology, or related fields may also be considered. Industry Experience: 1 year experience in the pharmaceutical, biotechnology, or medical device industry is often preferred. This could include experience in clinical research, medical affairs, or related roles that have exposed the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise: Demonstrated knowledge and expertise in the specific therapeutic area relevant to the position. This may involve experience working on clinical trials, publications, or direct patient care in that therapeutic area. Scientific and Clinical Knowledge: A strong understanding of medical and scientific principles, including knowledge of clinical trial design, data analysis, and interpretation. Familiarity with relevant disease states, treatment guidelines, and emerging trends in the therapeutic area is also important. Communication and Relationship-Building Skills: Excellent interpersonal, communication, and presentation skills are crucial for a RMA role. The ability to effectively communicate scientific information to various stakeholders, including Key Opinion Leaders (KOLs), healthcare professionals, and internal teams, is essential. Analytical and Problem-Solving Skills: RMAs are often required to analyze complex scientific data, identify insights, and provide recommendations. Strong analytical and problem-solving skills are valuable for interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility: RMAs often work in dynamic and fast-paced environments, requiring the ability to adapt to changing priorities and work independently. Flexibility to travel frequently to engage with external stakeholders is also often required. Regulatory and Compliance Knowledge: Familiarity with relevant legal, regulatory, and compliance guidelines, such as Good Clinical Practice (GCP), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulations governing medical communications. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 04/20/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. Scope external study data requirements and effort for projects. Project manage all external data related activities across multiple projects. Provide expert advice on the transfer and expected formats of data transfer files. Provide technological expertise and guidance on the best methods for handling laboratory data and other external data. Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate. Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks. Ensure data integrity is maintained by implementing appropriate data controls for masked data. Ensure delivery of timely data transfers and undertake quality reviews and testing activities. Conduct external data reconciliation using available technologies and processes. Raise queries to external data providers and track queries to successful resolution. Provide listings to medical review team. Assess and implement new data review and analysis processes and technologies. Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters. Provide training and mentoring to team members in SOPs, software applications, and best practices. Attributes and Skills-Expert domain knowledge and experience within clinical research and drug development. Advanced knowledge in >1 EDC systems and laboratory processes. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities. Excellent analytical, communication and problem-solving skills. Responsibilities The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. Scope external study data requirements and effort for projects. Project manage all external data related activities across multiple projects. Provide expert advice on the transfer and expected formats of data transfer files. Provide technological expertise and guidance on the best methods for handling laboratory data and other external data. Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate. Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks. Ensure data integrity is maintained by implementing appropriate data controls for masked data. Ensure delivery of timely data transfers and undertake quality reviews and testing activities. Conduct external data reconciliation using available technologies and processes. Raise queries to external data providers and track queries to successful resolution. Provide listings to medical review team. Assess and implement new data review and analysis processes and technologies. Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters. Provide training and mentoring to team members in SOPs, software applications, and best practices. Attributes and Skills Expert domain knowledge and experience within clinical research and drug development. Advanced knowledge in >1 EDC systems and laboratory processes. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities. Excellent analytical, communication and problem-solving skills.

Responsibilities : - Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations. Conduct & review of toxicology risk assessments for excipients, impurities, solvents, extractables and leachables, ensuring adherence to regulatory standards. Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines. Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies. Develop and compile PDE and OEL monographs to support safety evaluations. Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions. Manage preclinical studies and associated documentation to ensure compliance and accuracy. Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines. Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment. Provide expert guidance in addressing client and regulatory inquiries effectively. Background Required - Qualified Toxicologist Signing non-clinical/ toxicological reports/ modules/ expert reports Drafting of Environmental risk assessment reports Due diligence of pre-clinical data and drafting strategy for non-clinical studies for complex generics, NCEs, Biologics etc Drafting and review of non-clinical CTD modules Drafting of PDE reports Toxicological risk assessment of impurities/ leachables/ extractables Required education: Qualified and experienced Toxicologist Required experience : At least 2 years of experience in above mentioned activities.

Job title: Principal Data Standards Analyst Location: IN / Hyderabad Grade: L2-2 Hiring Manager: Manuel Anido About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. ReadyAs Principal Data Standards Analyst within our Clinical Information Governance, As a member of a CIG (Clinical Information Governance) team, the Principal Data Standards Analyst acts as a metadata expert as he/she provides in-depth knowledge and guidance on clinical data standards (CDISC) and best practices for metadata management across global and study-specific levels. Understand the CDISC models (CDASH, SDTM, External Data, Controlled Terminology) and all regulatory requirements regarding Data Standards. Actively leads Therapeutic Area Working Groups. The Principal Data Standards Analyst will bridge the gaps between global metadata strategy and its adoption within therapeutic area studies. The Principal Data Standards Analyst represents Sanofi in all internal external networks initiatives (CDISC, TransCelerate, etc.), monitor actively Health Authorities requirements, and promotes Data Standards knowledge and best practices within Sanofi. At the study level, the Principal Data Standards Analyst supports clinical teams in supervising the review of study-specific metadata based on customer needs and provides effective solutions through regular analysis of information reported from a broad variety of sources. Are you ready to shape the future of medicineThe race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Clinical Information Governance team as Principal Data Standards Analyst and you ll help shape the future of Clinical Data Standards at Sanofi and across our industry. Main responsibilities: Acts as a Metadata Lead Expert for CDASH, SDTM, External Data and Controlled Terminology. Understands the application of the CDISC models across the life cycle of a trial. Leads Global/Study Request Review Meetings. Leads eCRF review (study level) with the Study Team and ensure study-specific metadata are aligned with the CIG Clinical Data Standards strategy. Review of study requests (Data Collection, External Data, Controlled Terminology, SDTM). Develop CDISC-compliant end-to-end metadata specifications for new study-specific forms. May lead the creation and upload of study-specific controlled terminology (CT) in the Clinical Data Repos system. Support Clinical Data Standard Leaders with the management of global requests (review/meeting/implementation in Sanofi Metadata/metadata QC/standard documentation updates). Participate in Core and TA standard needs definition (SDTM and TA WG). Contribute to Global governance process definition and/or optimization. Monitor study-specific forms developed with Standard potential at the Therapeutic Area level. About you Experience : Relevant professional experience in Pharmaceutical Industry, with strong involvement in the clinical data flow , specialized in Data Standards Management. Strong knowledge of industry data standards and practices (e.g., CDISC/CDASH/SDTM). Having High level CDISC skills and Metadata Governance practices. (Preferred CDISC certification in one of more of the models). Familiar with end-to-end clinical data flows and data structures. Soft and technical skills : Strong English skills (verbal and written), ability to exchange fluently in a global environment. Efficient communication skills and good organization skills. Ability to negotiate and gain acceptance of others. Ability to coordinate/oversee multiple tasks simultaneously. Project team collaboration by interacting with internal or external partners in/outside the Department and with their leaders. Self-motivated results driven with attention to detail and quality. Education : Bachelor s degree or above, preferably in Life Science or related field Languages : Excellent English language knowledge - written and spoken. Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks gender-neutral parental leave. This role is critical to our team s success and provides exposure to industry-wide developments of Data Standards. It is an opportunity to become a leader within a network of subject matter experts collaborating to shape the future of Data Standards for Clinical Research. Pursue progress , discover extraordinary 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, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Working with Us 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 rich in diversity Take your career farther than you thought possible 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 At Bristol Myers Squibb, we are inspired by a single vision transforming patients' lives through science In oncology, hematology, cell therapy, immunology, cardiovascular and neuroscience disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change We bring a human touch to every treatment we pioneer Join us and make a difference Position Summary Manager 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 Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e g , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 5 years programming experience in industry recommended Experience in reporting for Clinical Pharmacology studies is preferred Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs Have in-depth understanding of clinical data structure (e g CDISC standards) and relational database Demonstrated skills in using software tools and applications, e g , MS office, XML, Pinnacle 21 Demonstrated ability in the handling and processing of upstream data, e g , multiple data forms, workflow, eDC, SDTM Demonstrated ability in providing outputs to meet downstream requirements, e g , ADaM, Data Definition Table, e-submission Have good understanding of regulatory, industry, and technology standards and requirements Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs Demonstrated ability to work in a team environment with clinical team members 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 Uniquely Interesting Work, Life-changing Careers 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 On-site Protocol BMS has a diverse 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 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

Working with Us 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 rich in diversity Take your career farther than you thought possible 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 Data Review Responsibilities will include, but are not limited to: Understand and review Protocol along with relevant data review documents (e g Protocol Data Review Plan, Data Quality Management Plan) Review clinical data listings Manage and facilitate resolution of data discrepancies Perform data cleaning as per the defined Clean Patient Group Freezing & Locking of CRFs/Fields Coordinate with Data Management Lead for study deliverables External Data: complete review of loaded external data Track data load and address discrepancies Coordinate with external data vendor for resolution of data discrepancies as applicable Documentation: Filing of appropriate documents in eTMF as per eTMF master plan Bachelor's Degree required Life sciences, Pharmacy or relevant fields preferred 2 years of experience in Clinical Data Review tasks Able to work on clinical data review tasks Able to work collaboratively on multi-disciplinary project teams Basic knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Good knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills Good oral and written communication skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) 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 Uniquely Interesting Work, Life-changing Careers 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 On-site Protocol Responsibilities BMS has a diverse 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: 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

Work Flexibility: Hybrid What you will do Generate statistical summary tables, patient data listings, and reports using SAS. Handle complex SAS programming issues , perform database and CRF review to ensure programming consistency, and be familiar with all study programming issues. Contribute to statistical analysis plans. Prepare template and programming for periodic progress reports for assigned clinical programs. Compile clinical data and relevant back-up material and present these results to the Biostatistics Manager for review. Work on SAS programs to generate data sets, tables, listings, and graphs. Work on SAS programs to complete quality control and validation work on SAS programs, data sets, and TLGs generated by others. Work on SAS programs to process and/or import external data into analysis data sets or export SAS output to other computer files for delivery. Work on SAS programs to create derived variables and data sets (e. g. , LOCF (Last Observation Carry Forward), adverse events with multiple merging and cleaning procedures), or perform other required advanced data manipulation to support completion of biostatistics projects; SAS, SQL & Macro skills required. May be required to assist in other programming tasks using software other than SAS to support biostatistics or specialized data analysis requirements. Assist with documents to describe SAS programs as assigned, such as specifications for protocol analysis data sets. Perform group and departmental Quality Control (QC) procedures. Work on listings to support data cleaning and monitoring. What You Need: Bachelors Degree or equivalent in biostatistics, statistics, or related field The ideal candidate will have at least 5-8 years of experience in SAS programming and analysis of clinical trial data. Familiarity with clinical trial design and analysis issues. Experienced with electronic data capture (EDC) system(s). Travel Percentage: 10%

ROLE SUMMARY A productive, hand on programmer who applies technical knowledge of CDISC and practical experience to deliver statistical programming deliverables leveraging CDISC constructs: SDTM, ADaM, and Control Terminology Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible Ensures adherence to high quality programming standards in their daily work ROLE RESPONSIBILTIES Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC , ADaM, and TLF generation. Demonstrate experience working as part of a software development team and fundamental SDLC processes. Ensures excellence in the understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible. Ensures adherence to Pinnacle 21 CDISC validation checks and high-quality programming standards in their daily work. Exhibits routine and occasionally complex problem-solving skills, seeking direction when appropriate. Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place. Will be knowledgeable of software development practices as defined within Pfizer s CDISC development framework. May contribute to department level initiatives. QUALIFICATIONS Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field At least 5 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency Statistical Programming and SAS hand-on experience Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data. Good understanding of ICH and regulatory guidelines Working knowledge of clinical data and relevant data standards Strong written and oral communication skills, and project management skills Proven ability to operate with limited oversight. Knowledge of at least 1 Therapeutic Area Proven ability to manage delivery under tight timelines. CDISC experience require. Pfizer CDARS experience desirable. Work Location Assignment: Flexible Work Location Assignment: Flexible Work Location Assignment: Hybrid Medical #LI-PFE

Summary Internal Role Title: Clinical Research Medical Advisor Location: Mumbai #LI-Hybrid About the Role: We are seeking a highly skilled and motivated Clinical Research Medical Advisor (CRMA) to join our team. The CRMA will be accountable for all country clinical or medical aspects associated with Development and prioritized Research programs/trials. This role involves providing clinical strategic and tactical leadership, optimizing clinical trial implementation, and ensuring adherence to safety standards and clinical data quality. About the Role Key Responsibilities: - Provide clinical development and indication expertise specific to the country/cluster. Validate study designs and make final decisions on clinical/medical trial feasibility. Contribute to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up. Provide clinical/medical expertise to clinical trial operations team members and clinical trial sites for IRB/EC interactions. Develop clinical/medical trial plans to ensure successful trial implementation. Provide robust indication, compound, and protocol training to the clinical operations team and externally as needed. Support and partner with internal stakeholders regarding clinical trials. Essential Requirements:- Scientific degree MD/M.B.B.S Ability to manage a study from the scientific/medical/clinical perspective. Demonstrated capability to problem solve and mediate complex issues. Effective leadership and communication skills. Agility to move quickly across different therapeutic areas and indications. Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice. Sound understanding of the overall clinical development process and ICH/GCP principles.

We are looking for a Associate STEM Content Analyst to join our Policy/Restrictions Content team Team in Bangalore. This is an amazing opportunity to work on ever-growing market access field. This is a clinically oriented role which focuses on research, data entry and analysis of restrictions policy data. This detail-oriented role requires extreme accuracy, a high level of clinical knowledge. Knowledge, Skills, and Abilities Required: Bachelor s or master s degree in Pharmaceutical Sciences Advanced computer literacy, knowledge of Microsoft Office Suite Understanding and interpreting clinical data Excellent oral and written communication skills It would be great if you also had 1 to 3 years of strong familiarity with Market Access/Managed Care data/PBM Proven track record of working in a team environment. Ability to adapt to ever changing client and healthcare market demands. What will you be doing in this role You will accurately source, research, evaluate, interpret, and enter Payer restrictions information into database for all therapeutic classes as assigned. Collaborate with the Restrictions team to ensure consistency in interpretation of data. Collection and appropriate storage of all supportive documentation for formulary and restrictions data. Assist in Automation Workflow as it pertains to Restrictions Policy Research. Assist in various Ad-Hoc Research Projects to meet Restrictions Deliverables for clients. About the Team The Market Access Policy team is responsible for the generation and maintenance of restrictions policy content working in close collaboration with stakeholders across Content Operations and the wider Life Science business. Our Policy team consists of colleagues based in India, US and Canada. Hours of Work 12 to 9 IST (including 1 hour break) Location - Bangalore At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions: Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (eg, coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Qualifications: Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.