627 Sdtm Jobs - Page 18

Summary The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables in Novartis Global Drug Development. About The Role Major accountabilities: 1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug D...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

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 Documen...

Secunderabad, India Software 2142 Job Description Overview Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. As a Senior Statistical Programmer , you will be responsible for programming s...

About the job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for ...

Company Overview Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission. Position Overview The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with s...

About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Team Lead Statistical Programmer will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for us...

🔹 Role-1: Statistical Programmer – SDTM (End-to-End) Location: Remote Experience: 4+ Years Job Description: We are hiring a Statistical Programmer with 4+ years of experience in end-to-end SDTM programming , including specification creation and SDRG preparation . Key Responsibilities: Develop and validate SDTM datasets in compliance with CDISC standards Interpret mapping specifications and raw data Prepare the Study Data Reviewer's Guide (SDRG) Collaborate with global clinical teams and statisticians Maintain documentation and ensure submission compliance Requirements: 4+ years of hands-on SDTM programming experience Proficient in SAS and CDISC implementation Strong knowledge of clinical tri...

Senior Programmer Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of one of our major pharma clients. Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skill...

About Saarthee: Saarthee is a Global Strategy, Analytics, Technology and AI consulting company, where our passion for helping others fuels our approach and our products and solutions. Our diverse and global team work with one objective in mind: Our Customers’ Success. At Saarthee, we are passionate about guiding organizations towards insights fueled success. That’s why we call ourselves Saarthee inspired by the Sanskrit word ‘Saarthi’, which means charioteer, trusted guide, or companion. Cofounded in 2015 by Mrinal Prasad and Shikha Miglani, Saarthee already encompasses all the components of Data Analytics consulting. Saarthee is based out of Philadelphia, USA with office in UK and India. Po...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

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

Position Summary: The Clinical Data Manager II is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The Clinical Data Manager II is able to assist and lead data management team and provide support to Lead Clinical Data Manager, develop project documentation, project plans, EDC system setup, data review and validation processes. Role & responsibilities Implements, monitors and supervises data management activities within assigned clinical trials, i.e., is responsible to design, create, valid...

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS repor...

Job Description: The ideal candidate will have over 4 years of experience working within Data Warehouse platforms in a regulated industry, specifically within a clinical trial environment (IDAR). This role demands a deep understanding of data visualisation tools, scripting languages, and SDTM data structures, along with the ability to work independently on complex assignments. Responsibilities: The service holder will be responsible to function in a continuous improvement framework with respect to systems deployment, life cycle management and enhancements supported user groups. The Analyst will contribute to initiatives to yield faster and more effective report development, efficient change ...

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vert...

Title - Associate Director - Data Product Manager GCL- E Typical Accountabilities: The role holder will execute the following accountabilities autonomously with limited supervisory oversight: Works with consumers / business users on the definition of the data requirements for intended data solutions. Able to translate unstructured, complex business problems into a data design and solution Profiling of data to understand provenance, quality, metadata models, ownership and compliance to internal and external regulatory standards Ad hoc wrangling of data (sourcing, extraction, profiling, integration) to support Data Science model generation and business insight Support of data engineers in the ...

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 Documen...

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

6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Job Title: Manager, Clinical Systems Location : Bangalore Foster a culture of continuous improvement by streamlining processes and adding value across the business Ensure high-quality work compliant with GCP, ICH guidelines, and all applicable regulations Oversee administrative activities such as time-sheets, training (iLearn and sponsor-specific), and leave management for the team Manage and support local and global Clinical Systems te...

Statistical Programmer – R Programmer (Remote opportunity) Location: Remote (India) Experience: 6 to 10 years About the Role: We are hiring a Statistical Programmer with strong R programming experience to join our growing team. This is a remote opportunity tailored for professionals passionate about clinical data analysis and programming, with expertise in CDISC standards. Key Responsibilities: Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in an FSP environment Debug and utilize standard macros effic...

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects. Key Responsibilities:. Write and optimize statistical code for data analysis and model development. Implement statistical methods for clinical trials, research, and business insights. Work with large datasets, ensuring the data is accurate, clean, and ...