275 Sdtm Jobs - Page 4

Skill required: Clinical Data Services - SDTM Mapping Designation: Clinical Data Svs Associate Qualifications: BE/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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.A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). What are we looking for Adaptable and flexibleAgility for quick learning 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 Qualification BE,Bachelor of Pharmacy,Master of Pharmacy

Description Mgr, Statistical Programming Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Minimum experience: 10 yrs 5 to 6 yrs of clinical Stat Programming exp, SDTM, ADAM, TLF Client engagement, communication, Must have exp of resource management, performance management. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Mgr, Statistical Programming

#hiring . Know anyone who might be interested? "Remote Opportunity" Veeda Lifesciences is seeking a passionate "Biostatistician II". Interested candidates can share an updated CV to mahendra.t3705@veedalifesciences.com Position Summary The Biostatistician II is responsible for collaborating with multiple Sponsors across several therapeutic areas in all phases of clinical trials and combining statistical expertise, technical knowledge on data processing and the ability to handle complex scientific/medical aspects of the study to efficiently support the Companys global clinical program. Role & responsibilities Acts under the supervision of more experienced biostatisticians of the Department, to provide statistical oversight and attend relevant project meetings Maintains and effectively communicates the status of analysis-related tasks to the Principal Biostatistician and given internal project managers of assigned studies, as appropriate Prepares Statistical Analysis Plans (including mock TFL shells) Works closely with the statistical programming team and performs statistical review of TFLs prior to Client delivery Reviews the CRF and other study specific documents, to ensure that the objectives of the study are covered Performs sample size calculation for Clinical Studies, under the supervision of more experienced biostatisticians Provides statistical input and reviews CSRs and protocols, under the supervision of more experienced biostatisticians Participates on the write-up of scientific abstracts, posters and manuscripts Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection

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. 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 . Position Summary The Senior Manager, Senior Solution Engineer, Drug Development Information Technology (DDIT) will be part of the product team committed to bridge the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, Global Biostatistics and Data Sciences, Clinical Data Management (Clinical Analytics, Site Selection, Feasibility, Real Word Evidence) The role is based out of our Hyderabad office, and is part of the Research and Development (R&D) BI&T data team that delivers data and analytics capabilities for across DD. You will be specifically supporting our Clinical Data Filing and Sharing (CDFS) Product line. This is a critical role that supports systems necessary for BMS' direct value change; regulated analysis and reporting for every trial in BMS Desired Candidate Characteristics:" Have a strong commitment to a career in technology with a passion for healthcare" Ability to understand the needs of the business and commitment to deliver the best user experience and adoption" Able to collaborate across multiple teams"" Demonstrated leadership experience Excellent communication skills" Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo" Agility to learn new tools and processes" As the candidate grows in their role, they will get additional training and there is opportunity to expand responsibilities and exposure to additional areas withing Drug Development. This includes working with Data Product Leads, providing input and innovation opportunities to modernize with cutting edge technologies (Agentic AI, advanced automation, visualization and application development techniques). Key Responsibilities Architect and lead the evolution of the Statistical Computing Environment (SCE) platform to support modern clinical trial requirements Partner with data management and statistical programming leads to support seamless integration of data pipelines and metadata-driven standards Lead the development of automated workflows for clinical data ingestion, transformation, analysis, and reporting within the SCE. Drive process automation and efficiency initiatives in data preparation and statistical programming workflows Develop and implement solutions to enhance system performance, stability and security Act as a subject matter expert for AWS SAS implementations and integration with clinical systems. Lead the implementation of cloud-based infrastructure using AWS EC2, Auto Scaling, CloudWatch, and AWS related packages Provide architectural guidance and oversight for CDISC SDTM/ADaM data standards and eCTD regulatory submissions. Collaborate with cross-functional teams to identify product improvements and enhancements. Administer production environment and diagnose & resolve technical issues in a timely manner, documenting solutions for future reference. Coordinate with vendors, suppliers, and contractors to ensure the timely delivery of products and services Serve as a technical mentor for development and operations teams supporting SCE solutions. Analyze business challenges and identify areas for improvement through technology solutions. Ensure regulatory and security compliance through proper governance and access controls. Provide guidance to the resources supporting projects, enhancements, and operations. Stay up to date with the latest technology trends and industry best practices. Qualifications & Experience: Master's or bachelor's degree in computer science, information technology, or related field preferred. 15 + years of experience in software development and engineering, clinical development or data science field 8-10 years of hands-on experience working on implementing and operation of different type of Statistical Clinical Environment (SCE) with Life Sciences and Healthcare business vertical. Strong experience with SAS in an AWS-hosted environment including EC2, S3, IAM, Glue, Athena, and Lambda Hands-on development experience managing and delivering data solutions with AWS data, analytics, AI technologies such as AWS Glue, Redshift, RDS (PostgreSQL), S3, Athena, Lambda, Databricks, Business Intelligence and Visualization tools etc. Experience with R, Python, or other programming languages for data analysis or automation. Experience in shell/ Python scripting and Linux automation for operational monitoring and alerting across the environment Familiarity with cloud DevOps practices, infrastructure-as-code (e.g., CloudFormation, Terraform). Expertise in SAS Grid architecture, grid node orchestration, and job lifecycle management. Strong working knowledge of SASGSUB, job submission parameters, and performance tuning. Understanding of submission readiness and Health Authority requirements for data traceability and transparency. Excellent communication, collaboration and interpersonal skills to interact with diverse stakeholders. Ability to work both independently and collaboratively in a team-oriented environment. Comfortable working in a fast-paced environment with minimal oversight. Prior experience working in an Agile based environment. 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 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. On-site Protocol Responsibilities 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: 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. 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 . Position Summary: The Senior Manager, Senior Solution Engineer, Drug Development Information Technology (DDIT) will be part of the product team committed to bridge the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, Global Biostatistics and Data Sciences, Clinical Data Management (Clinical Analytics, Site Selection, Feasibility, Real Word Evidence) The role is based out of our Hyderabad office, and is part of the Research and Development (R&D) BI&T data team that delivers data and analytics capabilities for across DD. You will be specifically supporting our Clinical Data Filing and Sharing (CDFS) Product line. This is a critical role that supports systems necessary for BMS' direct value change; regulated analysis and reporting for every trial in BMS Desired Candidate Characteristics:" Have a strong commitment to a career in technology with a passion for healthcare" Ability to understand the needs of the business and commitment to deliver the best user experience and adoption" Able to collaborate across multiple teams"" Demonstrated leadership experience Excellent communication skills" Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo" Agility to learn new tools and processes" As the candidate grows in their role, they will get additional training and there is opportunity to expand responsibilities and exposure to additional areas withing Drug Development. This includes working with Data Product Leads, providing input and innovation opportunities to modernize with cutting edge technologies (Agentic AI, advanced automation, visualization and application development techniques). Key Responsibilities: Architect and lead the evolution of the Statistical Computing Environment (SCE) platform to support modern clinical trial requirements Partner with data management and statistical programming leads to support seamless integration of data pipelines and metadata-driven standards Lead the development of automated workflows for clinical data ingestion, transformation, analysis, and reporting within the SCE. Drive process automation and efficiency initiatives in data preparation and statistical programming workflows Develop and implement solutions to enhance system performance, stability and security Act as a subject matter expert for AWS SAS implementations and integration with clinical systems. Lead the implementation of cloud-based infrastructure using AWS EC2, Auto Scaling, CloudWatch, and AWS related packages Provide architectural guidance and oversight for CDISC SDTM/ADaM data standards and eCTD regulatory submissions. Collaborate with cross-functional teams to identify product improvements and enhancements. Administer production environment and diagnose & resolve technical issues in a timely manner, documenting solutions for future reference. Coordinate with vendors, suppliers, and contractors to ensure the timely delivery of products and services Serve as a technical mentor for development and operations teams supporting SCE solutions. Analyze business challenges and identify areas for improvement through technology solutions. Ensure regulatory and security compliance through proper governance and access controls. Provide guidance to the resources supporting projects, enhancements, and operations. Stay up to date with the latest technology trends and industry best practices. Qualifications & Experience: Master's or bachelor's degree in computer science, information technology, or related field preferred. 15 + years of experience in software development and engineering, clinical development or data science field 8-10 years of hands-on experience working on implementing and operation of different type of Statistical Clinical Environment (SCE) with Life Sciences and Healthcare business vertical. Strong experience with SAS in an AWS-hosted environment including EC2, S3, IAM, Glue, Athena, and Lambda Hands-on development experience managing and delivering data solutions with AWS data, analytics, AI technologies such as AWS Glue, Redshift, RDS (PostgreSQL), S3, Athena, Lambda, Databricks, Business Intelligence and Visualization tools etc. Experience with R, Python, or other programming languages for data analysis or automation. Experience in shell/ Python scripting and Linux automation for operational monitoring and alerting across the environment Familiarity with cloud DevOps practices, infrastructure-as-code (e.g., CloudFormation, Terraform). Expertise in SAS Grid architecture, grid node orchestration, and job lifecycle management. Strong working knowledge of SASGSUB, job submission parameters, and performance tuning. Understanding of submission readiness and Health Authority requirements for data traceability and transparency. Excellent communication, collaboration and interpersonal skills to interact with diverse stakeholders. Ability to work both independently and collaboratively in a team-oriented environment. Comfortable working in a fast-paced environment with minimal oversight. Prior experience working in an Agile based environment. 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 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. On-site Protocol 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: 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.

Summary The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables in Novartis Global Drug Development. About The Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. 2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. 3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). 4. Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. 5. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. 6. Provide and implement statistical programming solutions; ensure knowledge sharing. 7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. 8. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12. As assigned, act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures. Key Performance Indicators (Indicate how performance for this job will be measured) : Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Program Statistician and the functional/operational manager. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager. Job Dimensions (Indicate key facts and figures) Number of associates: No direct reports. Coordination of 5+ internal and external programmers. Financial responsibility: (Budget, Cost, Sales, etc.) None Impact on the organization: Timely, high quality and efficiently produced statistical programming deliverables included in study and project level documents (incl. submissions) Reliable and compliant statistical analysis results presented externally (incl. submissions) Innovative technical solutions to support timely and efficient drug development deliverables Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written). Experience/Professional Requirement Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry 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: https://www.novartis.com/careers/benefits-rewards

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. 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 . Position Summary The Senior Manager, Senior Solution Engineer, Drug Development Information Technology (DDIT) will be part of the product team committed to bridge the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, Global Biostatistics and Data Sciences, Clinical Data Management (Clinical Analytics, Site Selection, Feasibility, Real Word Evidence) The role is based out of our Hyderabad office, and is part of the Research and Development (R&D) BI&T data team that delivers data and analytics capabilities for across DD. You will be specifically supporting our Clinical Data Filing and Sharing (CDFS) Product line. This is a critical role that supports systems necessary for BMS' direct value change; regulated analysis and reporting for every trial in BMS Desired Candidate Characteristics " Have a strong commitment to a career in technology with a passion for healthcare" Ability to understand the needs of the business and commitment to deliver the best user experience and adoption" Able to collaborate across multiple teams"" Demonstrated leadership experience Excellent communication skills" Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo" Agility to learn new tools and processes" As the candidate grows in their role, they will get additional training and there is opportunity to expand responsibilities and exposure to additional areas withing Drug Development. This includes working with Data Product Leads, providing input and innovation opportunities to modernize with cutting edge technologies (Agentic AI, advanced automation, visualization and application development techniques). Key Responsibilities Architect and lead the evolution of the Statistical Computing Environment (SCE) platform to support modern clinical trial requirements Partner with data management and statistical programming leads to support seamless integration of data pipelines and metadata-driven standards Lead the development of automated workflows for clinical data ingestion, transformation, analysis, and reporting within the SCE. Drive process automation and efficiency initiatives in data preparation and statistical programming workflows Develop and implement solutions to enhance system performance, stability and security Act as a subject matter expert for AWS SAS implementations and integration with clinical systems. Lead the implementation of cloud-based infrastructure using AWS EC2, Auto Scaling, CloudWatch, and AWS related packages Provide architectural guidance and oversight for CDISC SDTM/ADaM data standards and eCTD regulatory submissions. Collaborate with cross-functional teams to identify product improvements and enhancements. Administer production environment and diagnose & resolve technical issues in a timely manner, documenting solutions for future reference. Coordinate with vendors, suppliers, and contractors to ensure the timely delivery of products and services Serve as a technical mentor for development and operations teams supporting SCE solutions. Analyze business challenges and identify areas for improvement through technology solutions. Ensure regulatory and security compliance through proper governance and access controls. Provide guidance to the resources supporting projects, enhancements, and operations. Stay up to date with the latest technology trends and industry best practices. Qualifications & Experience Master's or bachelor's degree in computer science, information technology, or related field preferred. 15 + years of experience in software development and engineering, clinical development or data science field 8-10 years of hands-on experience working on implementing and operation of different type of Statistical Clinical Environment (SCE) with Life Sciences and Healthcare business vertical. Strong experience with SAS in an AWS-hosted environment including EC2, S3, IAM, Glue, Athena, and Lambda Hands-on development experience managing and delivering data solutions with AWS data, analytics, AI technologies such as AWS Glue, Redshift, RDS (PostgreSQL), S3, Athena, Lambda, Databricks, Business Intelligence and Visualization tools etc. Experience with R, Python, or other programming languages for data analysis or automation. Experience in shell/ Python scripting and Linux automation for operational monitoring and alerting across the environment Familiarity with cloud DevOps practices, infrastructure-as-code (e.g., CloudFormation, Terraform). Expertise in SAS Grid architecture, grid node orchestration, and job lifecycle management. Strong working knowledge of SASGSUB, job submission parameters, and performance tuning. Understanding of submission readiness and Health Authority requirements for data traceability and transparency. Excellent communication, collaboration and interpersonal skills to interact with diverse stakeholders. Ability to work both independently and collaboratively in a team-oriented environment. Comfortable working in a fast-paced environment with minimal oversight. Prior experience working in an Agile based environment. 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 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. On-site Protocol 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 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.

Job Title: Senior Business Analyst ( Saama Product ) Career Level - D1 Introduction to role AstraZeneca is currently looking for an IT Business Analyst/Business Systems Analyst to join our R&D IT Solution Delivery Team to manage and maintain our SaaMa product, which is GxP compliant and part of Clinical Development Platforms. This product is used across late science teams in all therapeutic areas. As a member of our BizDevOps team, you will work cross-functionally with other team members such as the Product Lead, DevOps Lead, and technical engineers. Accountabilities Collaborate with Business stakeholders - hold requirements elicitation sessions as well as backlog refinement sessions Document business requirements for the technical team (user stories with acceptance criteria) Work with business and technical staff to prioritize requirements that need to be delivered for each sprint Collaborate with the technical team to understand operational challenges Assist Release Manager and Product BA in roadmap and release planning Assist in coordination and supervision of the release process in terms of compliance artifacts - gather stories approvals, support Business stakeholders with BCR, BCCF, etc. Document BA-related processes and information in Confluence (ways of working, Jira-related information, etc.) Assist system owners in conducting help clinics and feedback sessions for end users to improve the overall quality of the platform Assist in the preparation of business cases to aid in decisions on system implementation Assist with system testing activities by creating/reviewing test cases and providing requirement clarifications to the testing team Contribute to regression testing activities by providing feedback on the test suite to ensure necessary functional requirements are covered and enhanced in every release Execute regression test cases independently or in association with the testing team Assist in creating or create UAT test cases that cover essential business scenarios/use cases Train testers from the business side on the functional aspects of the application Clarify any functional queries that may arise during testing activities Follow up with UAT testers, QM’s, and all relevant stakeholders to get sign-off on UAT Proactively drive identification of opportunities to be leveraged in solutions delivered Essential Skills/Experience Experience in Monitoring and Visualization Analytics Applications Experience in clinical data management, clinical data analytics, and visualization, clinical data programming experience Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics, and reporting Excellent understanding of common industry-standard business practices as related to clinical trials (study setup, clinical operations, data management, and reporting) Excellent knowledge of software development, testing processes, and methodologies and undeniable passion for business and system analysis Excellent written, verbal communication, and relationship management skills Able to work independently with minimum supervision Scrum Master Certification, Knowledge of Agile/Scrum methodology Experience working with JIRA, Confluence Experience of change management process in GxP validated SaaS environment Desirable Skills/Experience Self-motivation and an ability to contribute to rapidly evolving programs Working knowledge of CDASH, SDTM, ADaM, and CDISC controlled Terminology in the context of clinical data Experience in EDC (such as RAVE, Inform, Veeva) and Data Management Experience with and knowledge of tools that can help make software delivery and testing more effective Worked in a global organization where stakeholders and project team members are geographically dispersed Familiar with project management and business analysis software Knowledge and experience in Integration technologies like Mulesoft (or) Snap logic is a plus When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions while being supported all the way. Ready to make a difference? Apply now! Date Posted 30-Jun-2025 Closing Date 11-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Secunderabad, India Software 2142 Job Description Overview Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. As a Senior Statistical Programmer , you will be responsible for programming support in the analysis and reporting of clinical trials. You will work closely with biostatisticians, data managers, and clinical teams to develop high-quality statistical programming deliverables in compliance with regulatory requirements and industry standards. Responsibilities Develop, validate, and maintain SAS and R programs for data analysis, visualization, and reporting of clinical trial data. Generate CDISC SDTM datasets, analysis datasets (ADaM), tables, listings, and figures (TLFs) for clinical trial reports and regulatory submissions. Should be able to write the SDTM specifications and ADaM specifications based on the SAP and TFL shells. Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines. Collaborate with statisticians and clinical teams to interpret and implement statistical analysis plans. Provide technical leadership and mentor junior programmers in best practices for statistical programming. Perform quality control (QC) checks on programming deliverables to ensure accuracy and consistency. Participate in the development of standard programming macros and tools to improve efficiency and reproducibility. Support regulatory submissions by preparing submission-ready datasets and documentation within Pinnacle 21. Define xml and reviewer guide experience is a plus. Qualifications Minimum 8 years of experience in statistical programming within clinical trials or pharmaceutical/biotechnology industries. Proficiency in SAS programming with experience in Advanced SAS, SAS/STAT, and SAS Macro development. Strong experience in R programming for statistical analysis and visualization. Hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements. Solid understanding of clinical trial design, statistical methods, and regulatory guidelines (FDA, EMA, ICH). Experience working with clinical data from Phase I-IV studies. RWE study experience is a plus. Experience with other statistical software is a plus (Python, JMP, or other data visualization tools). Ability to work independently and collaboratively in a team environment. Strong problem-solving skills and attention to detail. Excellent verbal and written communication skills. Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

About the job Our Team: Sanofi Business Operations 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 Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: 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 (i.e., 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 followed, 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 (i.e., Observational) data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well 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 : Master's 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 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, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Company Overview Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission. Position Overview The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with sponsor requirements, preparing, documenting and testing necessary programs and ensuring that programming code adheres to regulatory and company standards. The role also involves performing quality assurance on work done by others, supporting production activities and assisting in training new employees. Primary Responsibilities Provides data to clients (internal and external) in functional format by: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications Assist with the creation of SAS-related project programming and validation documentation Assist with the creation of SAS macro and format libraries Ensures the quality of our client's data and data export by Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents Developing and implementing new CDM systems and enhancements to current CDM systems Understand, create, and communicate information about creating CDISC-compliant datasets Create documentation related to the generation of customer specific SAS datasets Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs Ensures project timelines as they relate to Clinical Data Management operations by Assessing and assigning target dates for project timelines in conjunction with manager Adhering to target dates for project timelines Communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of current issues Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by: Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures Assisting the training department with the development and maintenance of Clinical Programming training materials Secondary Responsibilities Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary Maintains Technical Knowledge by Attending and participating in applicable company sponsored training Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives Qualifications Education Bachelors degree in computer science, design or related field required Educational background in human-computer nteraction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus. Experience 8+ Years of experience, SAS programming experience in pharmaceutical related industry - Required 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases - Required 3+ Years of experience, Understanding of database organization and how to extract data to generate listings and reports - Required Additional skill set Ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Working conditions Travel: 5-20% Lifting: 0-25 lbs Other: Computer work for long periods of time THIS POSITION DESCRIPTION SHOULD NOT BE DEEMED ALL INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.

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 : Master's 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 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, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

🔹 Role-1: Statistical Programmer – SDTM (End-to-End) Location: Remote Experience: 4+ Years Job Description: We are hiring a Statistical Programmer with 4+ years of experience in end-to-end SDTM programming , including specification creation and SDRG preparation . Key Responsibilities: Develop and validate SDTM datasets in compliance with CDISC standards Interpret mapping specifications and raw data Prepare the Study Data Reviewer's Guide (SDRG) Collaborate with global clinical teams and statisticians Maintain documentation and ensure submission compliance Requirements: 4+ years of hands-on SDTM programming experience Proficient in SAS and CDISC implementation Strong knowledge of clinical trial data and regulatory standards Excellent attention to detail and communication skills ------------------------------------------------------------------------------------------------------------- 🔹 Role-2: Senior Statistical Programmer – SDTM, ADaM, TLF Location: Remote Employment Type: Full-Time Experience: 8+ Years Notice Period: Only Immediate or 1 Month notice period candidates will be considered Job Description: We are looking for a Senior Statistical Programmer with 8+ years of experience in SDTM, ADaM, and TLF programming for regulatory clinical trial submissions. Key Responsibilities: Design and develop SDTM and ADaM datasets per CDISC Program and validate Tables, Listings, and Figures (TLFs) Perform quality control and regulatory submission support Work closely with Biostatistics and Clinical Data teams Drive programming timelines and deliverables across studies Requirements: 8+ years of SAS programming in a clinical research environment Expert in SDTM, ADaM, and TLF generation Strong understanding of FDA/EMA submission standards Good communication, documentation, and collaboration skills

Senior Programmer Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of one of our major pharma clients. Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. How You Will Contribute Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data and analysis datasets Applying strong understanding/experience of Safety and Efficacy analysis Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties for assigned clinical study under principle programmers oversight Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change Being able to create specifications for derived/analysis datasets Generating and validating Non-CDISC transformation datasets and analysis datasets Proficient knowledge with SDTM/ADaM and TLF’s. General expertise with Figures Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP. Creating and reviewing submission documents and eCRTs They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides. R & complex macro writing are a plus What You Offer Bachelor’s or master’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. Familiarity with drug development life cycle and experience with the analysis and reporting of clinical trials’ data. Familiarity with ICH E3 (Structure and Content of CSR) and E9 (Stat Principles). Well conversant with regulatory requirements and drug development process. Study lead experience, preferably juggling multiple projects simultaneously. Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH Strong CDISC (both SDTM and and ADaM) experience is required. Solid ADaM and complex TFL skills. Strong QC / validation skills. Good ad-hoc reporting skills. Experience in pooling/ ISS/SE studies is an asset. Experience with cross-over studies is a plus. Submissions experience utilizing define.xml, creation of annotated CRF, data reviewer’s guides and other submission documents. Excellent analytical & troubleshooting skills. Being flexible to adapt and use client’s macro codes. R programming knowledge for data manipulation and graphs is an asset. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. Applied experience in one of the following therapeutic area is a plus: oncology, rare diseases, gastroenterology, respiratory, immunology, hepatitis and vaccines. Experience in medical affairs is a plus. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

About Saarthee: Saarthee is a Global Strategy, Analytics, Technology and AI consulting company, where our passion for helping others fuels our approach and our products and solutions. Our diverse and global team work with one objective in mind: Our Customers’ Success. At Saarthee, we are passionate about guiding organizations towards insights fueled success. That’s why we call ourselves Saarthee inspired by the Sanskrit word ‘Saarthi’, which means charioteer, trusted guide, or companion. Cofounded in 2015 by Mrinal Prasad and Shikha Miglani, Saarthee already encompasses all the components of Data Analytics consulting. Saarthee is based out of Philadelphia, USA with office in UK and India. Position Summary: We are looking for a skilled Statistical Programmer with strong R Programming experience to join our growing team. This is a remote opportunity tailored for professionals passionate about clinical data analysis and programming, with expertise in CDISC standards . Your Role Responsibilities and Duties: Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines. Perform efficacy analyses using R programming. Work independently on studies and support clinical trial submissions. Collaborate with cross-functional teams in an FSP environment. Debug and utilize standard macros efficiently. Preferred involvement in integrated summaries (ISS/ISE). Required Skills and Qualifications: 6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming. Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF. Exposure to efficacy analysis . Study-level handling experience (for senior-level profiles). Preferred Skills: Experience with CRT package (Trial Data Domain). Prior involvement in ISS and ISE . Experience in an FSP environment . Familiarity with standard macro debugging and utilization.

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. 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 . 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. 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 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. On-site Protocol 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: 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. 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 . 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. 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 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. On-site Protocol 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 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.

Bulk Hiring - Clinical SAS Programmer Mode: WFH-Permanent Salary:No Bar Skills: Statistical Programming /SAS Programming, SDTM, ADaM, TLF /TLG, Efficacy. Qualification: PG-degree in statistics, computing, life science-related field B.E/B.Tech.

Position Summary: The Clinical Data Manager II is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The Clinical Data Manager II is able to assist and lead data management team and provide support to Lead Clinical Data Manager, develop project documentation, project plans, EDC system setup, data review and validation processes. Role & responsibilities Implements, monitors and supervises data management activities within assigned clinical trials, i.e., is responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans and Data Management Plans Provides the study status updates with respect to data, using standard reports (CPT, data entry, queries, SDV, safety reconciliation etc.) and communicates efficiently the status to the team Creates and executes data quality checks throughout the study conduct Day to day responsibilities (under the guidance of senior personnel) may include but are not limited to: data review, open/close queries in the eCRF, medical coding, central lab data reconciliation, PK data reconciliation, ad-hoc data reports creation, User Acceptance Testing (UAT) of internal and external electronic Data Capture systems Provides support to the resolution of issues and inputs ideas to help resolve issues and contribute to continuous improvement Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection Key competencies: Excellent knowledge of CDISC/SDTM/ADAM specifications Excellent IT skills and MS Office command Ability and willingness to operate independently Ability to communicate effectively both verbally and in writing Ability to manage multiple and varied tasks and prioritize workload with attention to detail Demonstrate quality driven mindset while performing any of the assigned tasks Excellent knowledge of ICH/GCP, 21 CFR Part 11, guidelines and regulations, particularly those relevant to clinical data management Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice Professional Experience Requirements: Required: 8 Years experience as Clinical Data Manager Phase I -III Studies Desirable: Experience working with Medidata Rave Education Requirements: Required: BSc in Statistics, Biostatistics, Mathematics, Data Science or other applied sciences relevant field, life science, pharmacy or related subject or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) Desirable: MSc in one of the above fields

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS reports for DM function.( E.g., missing pages report, reconciliation report, patient profiles etc). Key requirements: 1) SAS Programmers with a minimum of 10 years of experience in clinical SAS programming. Python is good to have skillset. 2) Min 5 years of SAS experience with good understanding of DM and clinical stake holder requirements. Additional details: Responsibilities include (but not limited to) design, development, implementation, and validation of programs created in SAS dashboard applications, to process, analyze and report clinical trial data for review by clinical study teams. Works within established frameworks and ensures high quality is built into own deliverables. Works independently for well-defined scope of work Under guidance, creates catalogue of reports to aid data cleaning activities with moderate scope and medium complexity, but not limited to: Automate manual checks. Automate reconciliation and program edit checks for TPV data to ensure quality. Create tools and repository to minimize data errors at source for collection of lab reference ranges. Program reports to identify missing pages and also detect errors at Subject level. Create reports to measure metrics that can help assess data cleaning status. Create visualizations and dashboards to identify discrepancies in EDC and TPV data. Maintain created catalogue of reports and perform updates based on ongoing changes to requirements. Provide support as required to ensure availability and performance of developed reports and dashboards for both external and internal users Responsible for completion of documentation associated with programming tasks (e.g. peer review, report specifications etc.) in compliance with applicable SOPs Proactively keeps the lead programmers updated on progress of deliveries. Contribute to implementation of cross-functional projects that are part of clinical programming roadmap.

Job Description: The ideal candidate will have over 4 years of experience working within Data Warehouse platforms in a regulated industry, specifically within a clinical trial environment (IDAR). This role demands a deep understanding of data visualisation tools, scripting languages, and SDTM data structures, along with the ability to work independently on complex assignments. Responsibilities: The service holder will be responsible to function in a continuous improvement framework with respect to systems deployment, life cycle management and enhancements supported user groups. The Analyst will contribute to initiatives to yield faster and more effective report development, efficient change management services for analytics platforms. The analyst will have technical expertise with clinical data and report building, and experience gained through working with diverse and complex business processes and associated system infrastructures. The Analyst is required to work in a matrix environment across functions and departments What Required: More than 4 years experience as a Business Analyst, working within Data Warehouse platforms in a regulated industry within a clinical trial environment (IDAR) In depth knowledge of Tibco Spotfire, Power BI or Tableu or other equivalent visualization development tool Hands on experience of Python, R, SAS and similar scripting languages [Must] Hands-on of SDTM data structure (for IDAR) [Must] Knowledge to gather requirements and writing user requirement documentation Ability to work independently on assignments of moderate to high complexity without support. Interested candidates may share resume with Puja.k@maxisclinical.com

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 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.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Update BOT query sheet as and when requested by the TDM.Ensure completeness and validity of clinical as well as external data.Generate missing page report and track missing pages, as required.Track discrepancy and query status of assigned studies/Investigative sites as applicable.Review data from first data received to last data received and for selected tasks supporting the interim analysis/final database lock by operating in a continuous cleaning process.Perform DD pass activities as needed.Perform review for SDTM Data sets (SITS), P21 and other applicable reports.Share the weekly study metrics with TDM.Act as back up for TDM and lead study related meetings/document MOM and perform task allocation applicable for Data Manager, as needed.Upload standard reports/manual listings (DQPM listings) to central client location as guided by Lead Data Manager or client counterparts.Maintain an issue log to track and resolve discrepancies. Ensure issue clarification/follow-up until closure per the Issue Escalation Process/guidelines, as applicable.Interact with the TDM/Lead regarding data quality issues and assist them in tracking, monitoring the progress of data review activities.Accountable for high quality and on time delivery for assigned deliverables.Achieve the applicable SLA/KPI metrics. Qualification Bachelor of Pharmacy

Title - Associate Director - Data Product Manager GCL- E Typical Accountabilities: The role holder will execute the following accountabilities autonomously with limited supervisory oversight: Works with consumers / business users on the definition of the data requirements for intended data solutions. Able to translate unstructured, complex business problems into a data design and solution Profiling of data to understand provenance, quality, metadata models, ownership and compliance to internal and external regulatory standards Ad hoc wrangling of data (sourcing, extraction, profiling, integration) to support Data Science model generation and business insight Support of data engineers in the development of Source to Target pipelines (e.g. ETL design) Design & testing of the quality and performance of derivative data models in reporting and analytics solutions Processing of requests for compliant access to data Defining and managing information lifecycle management in data solutions Provision of data understanding (structure, provenance, quality) to Architects, Data Engineers and Data Scientists to support use in Analytics projects. Supports IT and business data teams in identifying and managing Critical Data Assets and Elements including Reference, Master and Metadata. Collaborates with Risk, Assurance, Privacy, Information Security and Regulatory authorities to ensure data and information controls are in place and adhered to. Clearly and objectively communicate insights and results, as well as their associated uncertainties and limitations Guidance of junior Data Analysts – supervision of task completion, support in trouble shooting challenges and contributing to performance evaluation reports Sharing of insight and best practice in community forums supporting capability development. Personal development and training in more complex data analysis skills, techniques and tooling Provision of domain data expertise (data standards, systems, metadata models, policies, business processes) in at least 1 domain area (e.g. chemistry, finance) and will be developing expertise in further domains Working with senior personnel they will contribute to Development of best practice for Data Analysis: Methods and Technology: technology evaluation, POCs Provision of training and skill development in the best practice of Data Analysis: training materials, FAQs, Playbooks and integrated operating models. 3 Key Specialisms Include: Source Data Analysts: Support engineers build/configure source applications by defining the data requirements and modeling the appropriate data structures for given use cases. They define data quality criteria to ensure data quality integrity of the application, develop logical data models (compliant to any RMDM standards), ensure that the project deliverable aligns with the logical design and business requirements (requirements traceability). Integration Data Analyst: Support engineers build composite analytics applications by defining data requirements, data structures and data integration paths. They will identify, profile and quality assess potential source data sets, understand and comply with any data restrictions (e.g. GDPR, License, IDAP controls, etc), develop integration patterns (ETL design), support the design of target data models (compliant to any MDM standards) and document to support re-use and management of the application. Data Steward: defining and managing data governance policies, standard and operating processes; the facilitation and operation of data and information governance activities; data quality issue management; the establishment and operation of governance controls including data access, lifecycle and metadata management; risk based approach to remediation and mitigation planning. Typical People Management Responsibility (direct / Indirect Reports): Approximate number of people managed in total (all levels) - 2-3 Manager of a team Matrix Manager – (projects/dotted line) Essential: Education, Qualifications, Skills and Experience: Undergraduate degree in a Computer Science, Data Management or possibly discipline area (R&D, Finance, HR etc) and cross trained or equivalent number of years of experience; Proven experience in a data analyst or business role aligned to data and information management role with practical examples of performing data analysis in terms of defining requirements, gleaning critical data elements, defining data quality criteria and checkpoints; Domain data understanding: the structure, provenance and meaning of the source data crucial to the domain (eg. SAP for Finance, SDTM for Clinical). Understanding of the business processes in the generation and consumption of data Desirable: Post-graduate degree in MIS, Data Management Essential: Skills and Capabilities: The role holder will possess a blend of data requirement analysis, data quality analysis, data stewardship skills; Experience in translating requirements into fit for purpose data models, data processing designs and data profile reports Experience in the use of data modeling technologies; Experience in working in multi-skilled, multi-location data teams, working to agile principles.; Knowledge of key AZ policies and standards for data covering areas such as privacy and security.; Excellent written and verbal communication, and consultancy skills; Awareness of the end to end processes and activities in the build and support of Data solutions; Experienced in applying a risk based methodology to data and information management; Experience in the use of metadata cataloguing tools; Experience of Data Analysis enabling tool kits Desirable: Leading the work of others – task setting, supervision and coaching of more junior staff Key Relationship To Reach Solutions: Internal (to AZ or team): Working with peers and team leaders in the business and IT in the delivery of data capabilities; Junior data analysts in supervising delivery; Data engineering teams to deliver data structures and data provisioning processes; Data Science teams supporting ad hoc data access and provision; Key assurance teams including Risk, Privacy Information security and audit; Other data analysts across AZ to develop and extend data analysis approaches and best practices External (to AZ): Outsource partners to deliver and support data structures and data provisioning processes Date Posted 19-Jun-2025 Closing Date 23-Jun-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Job Title: Senior Business Analyst ( Saama Product ) Career Level - D1 Introduction to role AstraZeneca is currently looking for an IT Business Analyst/Business Systems Analyst to join our R&D IT Solution Delivery Team to manage and maintain our SaaMa product, which is GxP compliant and part of Clinical Development Platforms. This product is used across late science teams in all therapeutic areas. As a member of our BizDevOps team, you will work cross-functionally with other team members such as the Product Lead, DevOps Lead, and technical engineers. Accountabilities Collaborate with Business stakeholders - hold requirements elicitation sessions as well as backlog refinement sessions Document business requirements for the technical team (user stories with acceptance criteria) Work with business and technical staff to prioritize requirements that need to be delivered for each sprint Collaborate with the technical team to understand operational challenges Assist Release Manager and Product BA in roadmap and release planning Assist in coordination and supervision of the release process in terms of compliance artifacts - gather stories approvals, support Business stakeholders with BCR, BCCF, etc. Document BA-related processes and information in Confluence (ways of working, Jira-related information, etc.) Assist system owners in conducting help clinics and feedback sessions for end users to improve the overall quality of the platform Assist in the preparation of business cases to aid in decisions on system implementation Assist with system testing activities by creating/reviewing test cases and providing requirement clarifications to the testing team Contribute to regression testing activities by providing feedback on the test suite to ensure necessary functional requirements are covered and enhanced in every release Execute regression test cases independently or in association with the testing team Assist in creating or create UAT test cases that cover essential business scenarios/use cases Train testers from the business side on the functional aspects of the application Clarify any functional queries that may arise during testing activities Follow up with UAT testers, QM’s, and all relevant stakeholders to get sign-off on UAT Proactively drive identification of opportunities to be leveraged in solutions delivered Essential Skills/Experience Experience in Monitoring and Visualization Analytics Applications Experience in clinical data management, clinical data analytics, and visualization, clinical data programming experience Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics, and reporting Excellent understanding of common industry-standard business practices as related to clinical trials (study setup, clinical operations, data management, and reporting) Excellent knowledge of software development, testing processes, and methodologies and undeniable passion for business and system analysis Excellent written, verbal communication, and relationship management skills Able to work independently with minimum supervision Scrum Master Certification, Knowledge of Agile/Scrum methodology Experience working with JIRA, Confluence Experience of change management process in GxP validated SaaS environment Desirable Skills/Experience Self-motivation and an ability to contribute to rapidly evolving programs Working knowledge of CDASH, SDTM, ADaM, and CDISC controlled Terminology in the context of clinical data Experience in EDC (such as RAVE, Inform, Veeva) and Data Management Experience with and knowledge of tools that can help make software delivery and testing more effective Worked in a global organization where stakeholders and project team members are geographically dispersed Familiar with project management and business analysis software Knowledge and experience in Integration technologies like Mulesoft (or) Snap logic is a plus When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions while being supported all the way. Ready to make a difference? Apply now! Date Posted 03-Jun-2025 Closing Date 29-Jun-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in FSP.