178 Sdtm Jobs - Page 2

Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! 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. Principal Statistical Programmer Posted date Jun. 06, 2025 Contract type Full time Job ID R-228434 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! 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. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

India - Hyderabad JOB ID: R-214635 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 05, 2025 CATEGORY: Research Let’s do this. Let’s change the world. In this vital role you will collaborate with teams across multiple time zones to fulfill requests, clarify requirements, escalate issues, and deliver high-quality results. The Sr Associate Biostatistical Programming will report to a locally based Biostatistical Programming Manager. The Sr Associate Biostatistical Programming will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least four years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential. Responsibilities: Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications Provide technical solutions to programming problems within CfOR(Centre for Observational research). Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Manage all programming activities, according to agreed resource and timeline plans Ensure all programming activities on the project adhere to departmental standards Write and/or review and approve all programming plans Write and/or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test, validate and execute department-, product- and protocol-level macros and utilities Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings Participate in the recruitment of programming staff Actively participate in external professional organizations, conferences and/or meetings Provide input to and participate in intra-departmental and CfOR meetings Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) Manage staff performance and oversee staff assignments and utilization What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Bachelor’s degree and 3 to 5 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Diploma and 7 to 9 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience Preferred Qualifications: Experience in SQL, and statistical programming using SAS or R Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans Project fulfillment, statistical programming, issue escalation, results delivery Statistical programming: SQL required; SAS or R required; Python preferred Motivated to learn how to work with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies Hands-on programming role Expert statistical programming knowledge using SAS or R Required: SAS or R Required: SQL Preferred: Python Excellent verbal and written communication skills in English Ability to have efficient exchanges with colleagues across geographical locations Agile project management Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare OMOP common data model Drug development life cycle Statistics and basic epidemiology: Incidence and prevalence [Required for Regulatory RWE role]: CDISC (SDTM, ADaM) Scientific / technical excellence Oral and written communication, documentation skills Leadership Innovation Teamwork Problem solving Attention to detail Learning mindset What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Senior Data Engineer Category: Data & AI Location: Bangalore, Karnataka, IN Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflows? Do you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovation? If so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It includes: Design, implement, and maintain scalable data pipelines and integration solutions aligned with the overall data architecture and strategy. Implement data transformation workflows using modern ETL/ELT approaches while establishing best practices for data engineering, including testing methodologies and documentation. Optimize data workflows by harmonizing and securely transferring data across systems, while collaborating with stakeholders to deliver high-performance solutions for analytics and Artificial Intelligence. Monitoring and maintaining data systems to ensure their reliability. Support data governance by ensuring data quality and consistency, while contributing to architectural decisions shaping the data platform's future. Mentoring junior engineers and fostering a culture of engineering excellence. Qualifications Bachelor’s or master’s degree in computer science, Software Development, Engineering. Possess over 10 years of overall professional experience, including more than 4 years of specialized expertise in data engineering. Experience in developing production-grade data pipelines using Python, Data-bricks and Azure cloud, with a strong foundation in software engineering principles. Experience in the clinical data domain, with knowledge of standards such as CDISC SDTM and ADaM (Good to have). Experience working in a regulated industry (Good to have). About the department You will be part of the Global Data & AI team. Our department is globally distributed and has for mission to harness the power of Data and Artificial Intelligence, integrating it seamlessly into the fabric of Novo Nordisk's operations. We serve as the vital link, weaving together the realms of Data and Artificial Intelligence throughout the whole organi-zation, empowering Novo Nordisk to realize its strategic ambitions through our pivotal initiatives. The atmosphere is fast-paced and dynamic, with a strong focus on collaboration and innovation. We work closely with various business domains to create actionable insights and drive commercial excellence. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). Apply Now! Deadline 20th June 2025. Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Responsibilities Act as an internal Subject Matter Expert and Work independently to support various programming activities related to analysis and reporting of clinical study data. Perform as Statistical Programming Coordinator on projects and interact with Sponsors, Data Operation Lead and other functions as a key contact with regard to statistical programming issue. Use efficient programming techniques to produce and QC of derived datasets and TLF. Create/modify standard macros and applications to improve the efficiency. Develop wider knowledge of SAS and other relevant programming languages and processes. Understanding regulatory requirements concerning industry technical standards, maintain all supporting documentation in accordance with WSOPs/guidelines. Provide relevant training and mentorship to staff and project teams A graduate or Master degree in a relevant educational filed life science, computer, pharmacy, others. Proficiency in SAS and knowledge of programming and reporting process. Excellent experience with TLF, SAS coding, Macros, SQL, PROC reports, SDTM, ADAM(preferred) Requirements Knowledge of WSOPs/ICH-GCP and System Life Cycle methodologies. Excellent communication (written & oral) skills and strong leadership ability. Strong organizational skills, flexible to change and team work. Ability to manage complex projects and business operational skills Study lead experience. For Associate Manager and Manager Role you must have people management (LM)experience. First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent Competent in written English. Good communication skills. Show more Show less

Job Title: Analytics and Reporting (A&R) – Biometrics Dev Ops Lead Career Level: E Introduction to role Are you prepared to apply your expertise in biometrics and DevOps to make a real impact? As an A&R Biometrics DevOps Lead, you will be a key member of the A&R Product IT DevOps team, managing core A&R applications such as Entimice and SAS GRID. Collaborate with Platform Managers, Product Managers/Owners, Senior Platform Engineers, Release Managers, and Solution/Integration Architects to establish standard processes in software development, business analysis, solution design, enterprise software integration, and project management within the BizDevOps IT Platform Delivery Model. Accountabilities Collaborate with vendors and internal collaborators to define requirements and develop implementation plans. Monitor system change requests and ensure alignment to IT standards. Serve as Technical Subject Matter Expert (SME) for SAS-related applications. Provide guidance and assist in the preparation of system-related specifications and documentation. Maintain day-to-day application systems, identifying and solving issues. Ensure all production changes align with life-cycle methodology and risk guidelines. Work on application enhancements and upgrades as vital. Liaise with internal teams/vendors to address application issues. Communicate effectively with users during planned/unplanned outages. Follow good documentation practices by creating and publishing Knowledge Base Articles (KBAs). Create technical backlogs/Story/Epic in JIRA based on product priority. Essential Skills/Experience Biometrics (A&R) Domain/Technology Bachelor or master’s degree in computer science or life science related field with IT/CRO/Pharma experience with a total of 15 years of experience. Industry experience working or implementing solutions based on CDISC Clinical Reporting Standards (SDTM, AdaM, TLF Reporting). Minimum 7-8 years working experience in SAS GRID related administration. Accredited Certifications SAS Administration from Vendor. Good understanding of SAS Programming & shell scripting, reporting tools, infrastructure. Ensure system security and control procedures are implemented and maintained. Maintain configuration specification documentation for functional and integration configuration. Work with software vendors on product requirements and issues related to the platform. Knowledge of client-server networking and database management. Administration background in SAS Viya 3.5/4.0 environments. Experience with SAS Visual Analytics & Power BI highly preferred. Familiarity with shell scripting & groovy scripting. Experience in R and Python is an added advantage. End-to-end knowledge of clinical trial development processes and associated system landscape. Solid grasp of common industry standard business practices related to clinical trials. Strong knowledge of ICH/G guidelines, 21 CFR Part 11, clinical trial methodology, and software development lifecycle activities. Knowledge of support processes like Incident Management, Problem Management, Change Management. Knowledge or experience with JMP Clinical, JReview, StatXact, CR Toolkit, Pinnacle 21. IT Engineering: Expertise and engineering attitude to help design and implement Clinical Data Solutions adhering to Products on Platform Strategy. Demonstrable ability to handle diverse collaborators and ensure high satisfaction delivery. Ability to work independently in a dynamic environment. Good communication and interpersonal skills to lead customers in urgent situations. Experience in Gxp validated systems implementation and maintenance of applications. Knowledge of Identity management solutions based on AZURE, OKTA, Oauth, Ping Federate/AD technologies. Understanding database concepts for optimizing reporting, data mapping, and programming. Experience in developing Interfaces/Integration between on-premises and SaaS Platform enabled Products using API’s, Web Services (MuleSoft), and ETL (SnapLogic) tech enablers. Knowledge of using/creating build tools and CI/CD (maven, ant, gradle, Sonar). Experience with Cloud Platforms such as AWS, AZURE. Experience working with JIRA, Confluence, Bitbucket, Automated Testing tools. Experience working in agile teams using methodologies such as SCRUM and SAFe & leading a team of 5+ & working in an Agile DevOps model. Experience programming in Java or other object-oriented programming languages. Experience delivering or developing workshop material, training, gap analyses, or requirements gathering sessions with business and system collaborators. Certification in IT delivery framework, Scrum Master, DevOps Lead role. Participate in business requirement gathering and design activities with business & IT collaborators as part of scrum team. Perform delivery activities through Design/Build/Test/Deploy phases for regular releases on A&R platform. When we put unexpected teams in the same room, we fuel 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 daring world. At AstraZeneca, we demonstrate technology to impact patients' lives by developing life-changing medicines. We are a purpose-led global organization that pushes the boundaries of science. Our work directly impacts patients by redefining our ability to develop life-changing medicines. We empower our business to perform at its peak by combining ground breaking science with leading digital technology platforms and data. Join us at a crucial stage of our journey to become a digital and data-led enterprise. Here you can innovate, take ownership, experiment with groundbreaking technology, and solve challenges that have never been addressed before. Ready to make a difference? Apply now! Show more Show less

Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! 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. Principal Statistical Programmer Posted date Jun. 06, 2025 Contract type Full time Job ID R-228434 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! 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. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

Senior Data Engineer Category: Data & AI Location: Bangalore, Karnataka, IN Novo Nordisk Global Business Services ( GBS) India Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflows? Do you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovation? If so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It includes: Design, implement, and maintain scalable data pipelines and integration solutions aligned with the overall data architecture and strategy. Implement data transformation workflows using modern ETL/ELT approaches while establishing best practices for data engineering, including testing methodologies and documentation. Optimize data workflows by harmonizing and securely transferring data across systems, while collaborating with stakeholders to deliver high-performance solutions for analytics and Artificial Intelligence. Monitoring and maintaining data systems to ensure their reliability. Support data governance by ensuring data quality and consistency, while contributing to architectural decisions shaping the data platform's future. Mentoring junior engineers and fostering a culture of engineering excellence. Qualifications Bachelor’s or master’s degree in computer science, Software Development, Engineering. Possess over 10 years of overall professional experience, including more than 4 years of specialized expertise in data engineering. Experience in developing production-grade data pipelines using Python, Data-bricks and Azure cloud, with a strong foundation in software engineering principles. Experience in the clinical data domain, with knowledge of standards such as CDISC SDTM and ADaM (Good to have). Experience working in a regulated industry (Good to have). About the department You will be part of the Global Data & AI team. Our department is globally distributed and has for mission to harness the power of Data and Artificial Intelligence, integrating it seamlessly into the fabric of Novo Nordisk's operations. We serve as the vital link, weaving together the realms of Data and Artificial Intelligence throughout the whole organi-zation, empowering Novo Nordisk to realize its strategic ambitions through our pivotal initiatives. The atmosphere is fast-paced and dynamic, with a strong focus on collaboration and innovation. We work closely with various business domains to create actionable insights and drive commercial excellence. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). Apply Now! Deadline 20th June 2025. Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Manager, CSAR - Global Library What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Title: Principal SAS Programmer (Clinical) Location: Remote Work Type: 6-12+ Months Contract Salary: Market Qualifications/Requirements/Skills: B.S., M.S., or Ph.D. degree in statistics, biostatistics, computer science or closely related field with a minimum of 7 years pharmaceutical/medical device/CRO related experience as a SAS programmer analyzing clinical trial data Excellent working knowledge of Base SAS (including macro language, Proc SQL, and ODS), SAS/GRAPH, and SAS/STAT Good working knowledge of CDISC SDTM and ADaM models Experience in integrating ISS/ISE data preferred Experience using other statistical packages (e.g., S-plus, R) a plus Knowledge of and ability to adhere to GCP principles and relevant regulatory requirements An aptitude for quantitative problem-solving with the capacity to troubleshoot and work independently Ability to follow guidelines and specifications on validation procedures and data transfer procedures Strong communication skills with the ability to interface at all levels; comfortable communicating workload to assist in managing priorities Flexible; ability to adapt to changing priorities and work independently with minimal supervision Experience running SAS in a Windows environment Able to set realistic timelines for assigned tasks and follow through to completion Show more Show less

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects. This role supports the generation of real-world evidence (RWE) by programming and analyzing large-scale observational datasets. The ideal candidate will have strong SAS programming skills, familiarity with R, and experience working with healthcare claims, electronic health records (EHR), or registry data. Key Accountabilities: Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General: Develop, validate, and maintain SAS and R programs to support RWD analyses, including prevalence, treatment patterns, cost/utilization, and time-to-event studies Execute programming tasks using Client standard macros and environments within UNIX and AWS-based platforms Perform double programming and quality control (QC) checks in alignment with internal SOPs and KIMS system workflows Collaborate with statisticians, data scientists, and cross-functional teams to define specifications and deliverables Document programming processes and outputs in accordance with regulatory and internal audit requirements Contribute to the development and maintenance of internal R packages, Shiny apps, and Quarto documentation to support programming workflows Participate in onboarding and mentoring of new programmers, including training on client-specific tools and data environments Skills: Excellent analytical skills. Proficiency in SAS; working knowledge of R is highly desirable 3+ years of experience in statistical programming, preferably in a pharmaceutical or healthcare setting Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Familiarity with real-world data sources such as Optum, MarketScan, Flatiron, CPRD, or similar Experience with Snowflake, UNIX/Linux environments, and version control tools (e.g., Git). Strong understanding of data privacy, regulatory compliance, and audit-readiness in RWD contexts Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge and Experience: Competent in written and oral English. Good communication skills. Experience with OMOP/OHDSI standards and tools Exposure to project management tools like Monday.com Ability to work independently and manage multiple priorities in a fast-paced environment Education: Educated to degree level in a relevant discipline and/or equivalent work experience; Bachelor’s or Master’s degree in Statistics, Computer Science, Epidemiology preferred. #LI-REMOTE

Role: Senior Consultant - Clinical Programming Location: Pune Work Mode: Hybrid (4 Days WFO and 1 Day WFH) Experience: 10+ Years Key responsibilities include: Oversight of outsourced programming deliverables Maintain up to date advanced knowledge of programming software (e.g SAS) as well as industry requirements (e.g CDISC). Development and validation of SAS programs for analysis Review of study documentation (CRFs, SAPs, mock TLFs) Review CRFs/eCRFs and data management specifications documents; Statistical Analysis Plans/mock TLFs. Preparation of CDISC-compliant submission packages Lead data package preparation for electronic submissions. Review of CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewers guides, SAS programs...) Support during audits and regulatory inspections Automation, standardization, and process improvement Mentoring junior programmers and supporting internal tools and KPIs Requirements: 10+ years of experience in clinical programming, strong SAS expertise, knowledge of CDISC standards, regulatory submission experience, and CRO oversight. This role demands strong technical, organizational, and communication skills, with the ability to work in a global, fast-paced environment.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

Our Team About the job Sanofi Business Operations (SBO) 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 Associate Biostatistician will work with Medical Affairs biostatisticians and Sanofi Business Operations biostatistics and programming personnel to support and 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 Associate Biostatistician will ensure SOPs are followed and timelines and quality metrics are met. 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. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Support in 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) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) Review appropriate biomedical and clinical research literature related to assigned project(s). Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. About You Experience: Master's degree with 1-3 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 1-2 years. Soft skills: 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: Base and / or Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple indications in a therapeutic area. 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! null Show more Show less

Role & responsibilities Developing, testing, validating, and maintaining SAS programs to generate analysis datasets, tables, listings, and figures Working closely with data management and statistical teams to understand the requirements for each project Reviewing clinical trial data and addressing any data inconsistencies or errors Designing and implementing strategies to manage, clean and verify clinical trial data Performing statistical analysis on clinical trial data Creating and maintaining documentation for all SAS programs and processes Ensuring that all programming activities and processes performed are conducted according to standard operating procedures and good programming practices Contributing to the development of standard operating procedures, guidelines, and best practices for SAS programming Assist with the development of statistical analysis plans. Provide input into clinical trial protocols and case report forms. Ensure data consistency and integrity. Meet project timelines and deliverables. Additional: Knowledge of CDISC SDTM and ADaM data models. Qualifications Proven work experience as a Clinical SAS Programmer. Experience in developing and validating SAS programs in a clinical research environment. Strong statistical analysis skills. Attention to detail and problem-solving skills. Proficient in the use of SAS Macro language and other advanced SAS features. Excellent written and verbal communication skills. BSc or higher degree in Statistics, Mathematics, Computer Science or a related field Interested Candidates please send me updated resumes to pitchireddy.t@hetero.com

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! Show more Show less

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5467 Position Summary: The Senior/Principal Clinical Database Manager is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Provides operational and technical training to end users and junior staff. Additionally, the Senior/Principal Clinical Database Manager may play a lead role in internal software projects that require specialized programming and/or scripting. Qualifications: Minimum Required: Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline Bachelor’s and/or a combination of related experience Medidata Rave EDC Certified Study Builder Rave API integration experience using external vendor modules Rave Advanced Custom Function programming experience Other Required: Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of clinical research tasks. Excellent organizational and communication skills Professional use of the English language; both written and oral. Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) Experience in clinical database management system development. Experience in a clinical, scientific or healthcare discipline. Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong leadership and interpersonal skills Must be able to communicate effectively in the English language. Preferred: Oncology and/or Orphan Drug therapeutic experience Base SAS®, SAS/STAT and SAS/ACCESS software SAS Macro programming language Advanced experience in Database Management, object-oriented programming Veeva set up experience It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5655 Position Summary: The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May perform data entry for paper-CRF studies, as needed May perform quality control of data entry Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other required: 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients Experience in utilizing a clinical database management system Broad knowledge of drug, device and/or biologic development and effective data management practices Ability to undertake occasional travel Preferred: Understanding of dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

🎯 We’re Hiring: Statistical Programmer 📍 Location: Remote 🕒 Experience: 8–10 Years 🗓 Notice Period:15 Days - 30days ✅ Key Responsibilities: Lead statistical programming for clinical research studies Work with SDTM, ADaM, TLF, and Oncology datasets (safety & efficacy) Utilize SAS (and preferably R) for statistical analysis Ensure compliance with CDISC standards and industry dictionaries (e.g., MedDRA, WHO Drug, CTCAE) Collaborate with cross-functional teams and mentor junior programmers 🎓 Requirements: Master’s degree in Biostatistics, Mathematics, or related field 8+ years of hands-on programming experience in clinical trials Strong communication and leadership skills 🌟 Bonus: Prior experience in a CRO or pharma setting Passion for coaching and mentoring junior team members Show more Show less

Job Description SDTM Mapping with SAS,SQL End to End SDTM Mapping activities Spec creation Validation and CRF Experience and Skills Required Minimum 3+ years in End to End SDTM Mapping activities Location- Mumbai/ Pune/ Bangalore SDTM Mapping activities Skills Required RoleSDM Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills SDTM MAPPING ACTIVITIES Other Information Job CodeGO/JC/21472/2025 Recruiter NameSangeetha Show more Show less

Summary Our Associate Director, IT Solution Delivery is our senior specialist for project delivery and/or operations in the given business sub-capability. In this role, you will partner with business leaders and Technology Transformation Strategic Business Partners for demand analysis, solution proposal/evaluation and project delivery. The purpose of the role is to configure the Statistical Compute Environment (SCE) according to the defined requirements, as a member of the Prototyping and Development workstream. This role will configure off-the-shelf products, develop customizations and integrate IT solutions that meet the business needs and deliver business outcomes. You will collaborate with other project team members to deliver the SCE solution on time and within budget. About The Role Key Responsibilities: Manage a small team of developers for the SCE project to configure, customize, and integrate components of the SCE in an iterative manner. Responsible for detailed design, development and delivery of the SCE, in alignment with solution architecture and create the detailed process designs necessary to operate the software/service on a day-to-day basis. Take accountability for delivery of specific components / use cases for the SCE. Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of the SCE. Ensure peer review and sign off detailed designs by business. Ensure that detailed designs adhere to solution architecture design (i.e. high-level conceptual design) and are traceable to functional as well as non-functional requirements in functional specification. Ensure the overall user experience is taken into account when designing new solutions and services. Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope. Coordinate with all other workstreams on the project to deliver a quality SCE on time and within budget. Key Requirements Bachelor’s degree in Computer Science, Computer Engineering or related technical discipline or equivalent experience demonstrated. 7 years’ experience working in an IT environment with experience working in quantitative science/data science platforms, with a track record of delivering global IT solutions at scale, and interactions with senior management across geographical and organisational boundaries. Strong demonstrated experience in cloud implementations with Amazon Web Services (AWS). Advanced knowledge of Lean/ 6 Sigma, Design Thinking and Agile methodology with demonstrated comfort working within a Scrum team. Experience leading both direct and indirect reports in a matrix environment where you have leveraged digital technology and effective change management to deliver value. Experience in IT Enterprise & Business Architecture, IT Systems Design, IT Systems Integration, User Experience Design, Design Thinking, Analyzing stakeholder requirements, and Knowledge of IT Applications & tools Experience with the open source environment including; languages such as (e.g. R, Python, Julie), open source Posit (R Studio, R Shiny, etc.), open source packages (e.g. Quarto and Markdown), and open source technology administration & containerisation (Docker), with use of Git and Bit Bucket for CI/CD and use of red Hat Linux environments. Experience with build tools like Maven and Jenkins and EasyBuild tools. Proficiency in English (written and oral). Desirable Experience working on biostatistical quantitative science/ data science platforms, ideally within the pharmaceutical industry. Solid understanding of clinical trial processes and leveraging quantitative sciences and toolsets in regulatory and exploratory pathways. Understanding of different data modalities (ex. Biomarkers, Omics, Imaging). Strong knowledge of Clinical data standards (CDISC – SDTM, ADAM, USDM). Experience with AI/ML Experience with Domino Benefits & Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours. You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours Commitment To Diversity & Inclusion We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you 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 Show more Show less

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager, CSAR - Global Library What You Will Do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Show more Show less

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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.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

Job description Medtek is a data science driven company to support faster drug development and healthcare solutions.It support growing Biotech and Pharma companies. Assist clients with Data Technologies, Data Analysis, Data Mining, CDISC, Visualisation and Regulatory reporting. Support end to end Biostatistics, Programming and Data Management work. ESSENTIAL DUTIES AND RESPONSIBILITIES OF PRINCIPAL STATISTICAL PROGRAMMER- Able to independently Lead statistical programming activities for Phase 2/3 studies Able to multitask and work in a matrix environment 8 years experience in SAS programming and Reporting Able to program and deliver in independently with minimum guidance 6+ year of SDTM/ADaM and TLF Programming experience Able to write specification Independently validate others programs Able to work in multitasking environment and lead studies Proactive, multitask and able to work in matrix environment Pay attention to data and provide daily details Able to work in clinical domain with Clinician, Statistician and Scientist. In-depth knowledge of clinical trial design, statistical analysis, and regulatory guidelines. Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Development and execution of statistical analysis and reporting deliverables (e.g.safety and efficacy analysis datasets, tables, listings, figures) Provide technical guidance to other statistical programmers, and ensure training and development of team members. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Master in Statistics, computer science or analytics field with 7+ year experience Knowledge/Skills: Eight + year of Statistical programming experience Six year of experience with CDISC Two year Experience with SQL programming Experience in CDISC SDTM/ADaM domain Good communication skills Job Type: Full-time Pay: 25-30 Lacs P.A. Schedule: 8 hour shift Application Question(s): Can you write ADaM, SDTM specificaiton and programs ? Experience: statistical programming: 7 years (Required)

India - Hyderabad JOB ID: R-209284 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Mar. 04, 2025 CATEGORY: Clinical What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential. Responsibilities: Provide technical solutions to programming problems within CfOR(Centre for Observational research). Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Project manage programming activities, according to agreed resource and timeline plans Ensure programming activities adhere to departmental standards and SOPs Write and/or review and approve programming plans Write and/or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications Write, test, validate and execute department-, product- and protocol-level macros and utilities Oversee the work of outsourced resources assigned to projects Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings Participate in the recruitment of programming staff Actively participate in external professional organizations, conferences and/or meetings Provide input to and participate in intra-departmental and CfOR meetings Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) Manage staff performance and oversee staff assignments and utilization Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Bachelor’s degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience Preferred Qualifications: Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model. Experience: Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Team management Global collaboration Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery Statistical programming: SQL required; SAS or R required; Python preferred Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies Hands-on programming and lead role Expert statistical programming knowledge using SAS or R Required: SAS or R Required: SQL Preferred: Python Excellent verbal and written communication skills in English Ability to have efficient exchanges with colleagues across geographical locations Agile project management Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare OMOP common data model Drug development life cycle Statistics and basic epidemiology: Incidence and prevalence [Required for Regulatory RWE role]: CDISC (SDTM, ADaM) Scientific / technical excellence Oral and written communication, documentation skills Leadership Innovation Teamwork Problem solving Attention to detail What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Hi , We are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 83 b) To Apply for above Job Role ( Pune ) Type : Job Code # 84