627 Sdtm Jobs - Page 21

Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timefr...

Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. As an ISO-certified organization and partner of Medidata Rave, we are committed to excellence and trust in clinical research. We are seeking a highly motivated and skilled Clinical Statistical Programmer to join our dynamic Biometrics team. In this role, you will be instrumental in the development, validation, and maintenance of programs used for the analysis and reporting of clinical trial ...

The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysi...

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of...

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the glob...

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Senior SAS Programmers to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global develo...

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 Biostatis...

The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate® platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial. This includes study design in elluminate®, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using Mapper...

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and de...

Let’s build the future of medicine—together. Join Enveda as a Sr. Manager, Clinical SAS Programming in India and help us transform natural compounds into life-changing medicines. We’re a team driven by curiosity and innovation—are you ready to make a difference? Hybrid | India | Full-Time What Makes Us Enveda Life is smart, and we can learn from it. We’re reinventing drug discovery by harnessing nature’s intelligence. Our platform identifies new medicines four times faster than the industry standard—because patients can’t wait. What sets Enveda apart isn’t just what we do—it’s how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe “People...

TCS is hiring for Statistical Programmer!!! Job Location Mumbai/Pune/Bengaluru Experience Range 4 to 14 Years Educational Qualification(s) Required Any Life Science Graduate Interested can share their CV on babeeta.shahi@tcs.com Roles & Responsibilities:- Creation and validation of analysis data sets, tables, listings and figures . Creation and validation of ISS and ISE reports. . Development and testing of reusable Standard Programs . Development of SAS macros to work as utilities to automate routine activities . Remapping of old studies into ADaM structure . Build and maintain ADaM compliant Repository . Creation and validation of ADaM specification document . Assistance in creation of reg...

Sr. Statistical Programmer - FSP (India) Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members. Key Responsibilities Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project Codes complex SAS programs for applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from the supervisor Create specifications for derived/analysis datasets Program analysis data...

Key Accountabilities Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Provide leadership, project specific training, stakeholder management, external spons...

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 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 me...

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 epidemi...

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...

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, maint...

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. Accountabil...

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 me...

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 suppor...

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 positi...

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...

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 Accountabi...

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...