397 Sdtm Jobs

Company: TCS Role: Healthcare & Life Sciences Other Industry: Pharmaceutical & Life Sciences Department: Healthcare & Life Sciences Employment Type: Full-time, Permanent Role Category: Healthcare & Life Sciences Other Job Location: Mumbai, Pune, Bangalore, Delhi-NCR Experience Range: 512 years Position Overview TCS is seeking experienced Statistical Programmers with expertise in CDISC standards to support programming activities across multiple therapeutic areas. The role involves overseeing statistical programming deliverables, ensuring compliance with quality processes, and managing project timelines. Key Responsibilities Lead statistical programming activities for one or more compounds, in...

We are looking for a highly skilled Clinical Data Modeling Specialist with deep expertise in the Unified Study Data Model (USDM) to support the design, development, and governance of clinical and real-world data (RWD) models . The ideal candidate will have a strong background in data information modeling , healthcare data standards , and semantic interoperability , working cross-functionally to ensure scalable and compliant data solutions. Key Responsibilities: Design and develop data information models aligned with USDM for clinical trials and real-world data (RWD) . Collaborate with cross-functional teams to define and document LinkML schemas and metadata standards . Perform data curation ...

**Greetings from You & I Consulting!** We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming, this role is your next step forward! Senior Lead Statistical Programmer!!! We are hiring for: Senior Lead Statistical Programmer up to 22LPA ctc **To Apply Call on Puja- 8167854231 /Or Whatsapp on the same Number with your CV** Experience Level: 4 to 18 years Location-Mumbai , Kochi, Bangalore and PAN India Job Description : We are seeking an experienced and driven Senior Lead Statistical Programmer with 1015 years of experience in clinical trial prog...

Role & responsibilities Contribute to the design and implementation of AI augmented clinical data products (Protocol, ICF, CSR, etc.) and GxP-validated content generation for SDTM, ADaM, and TLG. Support development of Agentic AI solutions for specifications, data mapping, and metadata-driven workflows. Assist in delivering analysis-ready datasets for submission use cases. Collaborate in Agile projects, documenting requirements, writing user stories, and maintaining backlogs using JIRA/Retina. Participate in requirement discussions, creation of specifications, traceability, and user guides aligned with regulatory compliance. Engage with cross-functional teams to support AI-driven biometrics ...

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

TCS is hiring for Statistical Programmer!!! Job Location Mumbai/Pune/Bangalore/Delhi - NCR Experience Range – 5 to 12 Years Skillset Required – SDTM, ADAM, TFL Interested candidates are requested share updated CV with below details on the mail id – Babeeta.shahi@tcs.com 1. Experience in the statistical programming activities for one or more compounds/indications or a therapeutic area. 2. Manages a team of statistical programmers and the resource planning for their assigned projects. 3. Ensures timely deliverables, that all quality processes are followed and consistency within the projects. 4. Develops and oversees the development of SAS programs for the creation of ADaM data sets following C...

Summary Provide timely & professional ongoing Mgmt of Data Mgmt/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data with respect Provides comprehensive expertise for multiple or complex global clinical studies ensuring consistent and high-quality generation of specification, production, and validation of clinical data collection systems and associated metadata with high quality, on time, and within budget in accordance with project budgets. Interpret data collection requirements into data models of moderate complexity and uses relevant programming language to build EDC & warehouse setup. About the Role Major accountabilities: 1. Serves as the primary study lead ensu...

Job description Role & responsibilities: Overseeing the collection, validation and processing of clinical trial data. Developing and implementing data management procedures for clinical trials. Supporting and facilitating the review of medical coding for validity and completeness. Ensuring compliance with applicable regulations, protocols and standard operating procedures in India. Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock. Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management. Preferred candidate profile Certification in clinical data managemen...

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 a...

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas 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 ...

Summary The Clinical Database Programmer is primarily responsible for LSH Setup and Data Loading activities (both Inbound and Outbound) with External Data providers. Also provide support to manage the load, Transfer and conform Clinical Trial Data to Novartis Internal standards and the provision of Clinical Data extracts to Clinical Data Consumers of study-level or project level deliverables under minimal guidance. About The Role Major accountabilities: 1. Contribute to LSH and Data Loading activities as Clinical Database Programmer for phase I to IV clinical studies in Novartis Global Drug Development. 2. Participate in the review of Data Transfer specification documents and provide comment...

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical...

Python AI Engineer – Synthetic Test Data (Life Sciences / GxP) About the Role We are seeking a Python AI Engineer to design and implement intelligent frameworks for synthetic and automated test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems. This role will leverage AI/ML and Python automation to deliver high-quality, audit-ready datasets that reduce reliance on production data, accelerate testing cycles, and ensure compliance with FDA, EMA, and global regulatory standards. Key Responsibilities 🔹 Synthetic Test Data Automation Build Python frameworks to generate synthetic clinical and operational datasets. Produce CDISC-compliant datasets (SDT...

• Ensures that the Statistical Programming department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures(SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Statistical Programming department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and mai...

Position Summary: The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels a...

Experience with Amazon marketplace & other e-commerce portals. Responsible for uploading new Listings on Amazon on weekly basis Ensuring catalogue hygiene of the uploaded catalogue. Experience: 3 - 8 Years

Position: Senior Software Developer-Analytics *** JOB DESCRIPTION *** Overview: The Senior Software Developer will work closely with product manager, Implementation Consultants (ICs) and clients to gather requirements to meet the data analysis need of a company or a client. They must have good collaboration skills. The Senior Software Developer will provide direction on analytics aspects to the team on various analytics related activities. Key Tasks & Responsibilities: Experienced in Qlik Sense Architecture design and good knowledge on load script implementation and best practices. Hands on experience in Qlik Sense development, dashboarding, data-modelling and reporting techniques. Experienc...

Role Overview: As a Senior Statistical Programmer at ProcDNA, you will leverage your advanced SAS and R programming skills along with proficiency in CDISC standards to support or lead one or more Clinical studies. You will be part of a passionate team that focuses on creating game-changing Commercial Analytics and Technology solutions for clients globally. Innovation is not just encouraged at ProcDNA, it is ingrained in our DNA. Key Responsibilities: - Having 6+ years of experience in SAS & R Programming - Hands-on experience with SDTM, ADAM, TLF including safety and efficacy analysis - Experience with CRF annotation, creation of datasets, and specs creation - Submission experience is a plus...

Job title: Principal Data Standards Analyst Location: IN / Hyderabad Grade: L2-2 Hiring Manager: Manuel Anido About The Job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Principal Data Standards Analyst within our Clinical Information Governance, As a member of a CIG (Clinical Information Governance) team, the Principal Data Standards Analyst acts as a metadata expert as he/she provides in-depth knowledge and guidance on clinical data standards (CDISC) and best practi...

Biostatistician I About The Role : We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards. Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment. Key Responsibilities: Conduct statistical analyses as outlined in statistical analys...

About Apexon: Apexon is a digital-first technology services firm specializing in accelerating business transformation and delivering human-centric digital experiences. We have been meeting customers wherever they are in the digital lifecycle and helping them outperform their competition through speed and innovation. Apexon brings together distinct core competencies – in AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering and UX, and our deep expertise in BFSI, healthcare, and life sciences – to help businesses capitalize on the unlimited opportunities digital offers. Our reputation is built on a comprehensive suite of engineering services, a de...

Summary Assist in the timely & professional ongoing Mgmt of data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team. Ensure high quality data available for secondary analysis use. Support content development and upgrade to training modules into engaging and interactive applications. Follows data regulations and laws, data-handling procedures and data mapping guidelines. Supports quality deliverables within Clinical Data Operations (DO). Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical D...

About ProcDNA: ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA. What we are looking for: As a Senior Statistical Programmer, you will leverage your advanced SAS /R programming skills and proficiency in CDISC standards (SDTM , ADaM, TLF with both safety and efficacy ana...

You will be part of our team as a Senior SAS Programmer, where you will be responsible for providing SAS programming support for TFL generation and offering statistical/programming inputs for CRF design and review. Additionally, you will be involved in developing and validating standard and ad-hoc SAS macros. You will carry out reviews of CRF and aCRF, statistical analysis plans, and programming specifications for efficacy variables. Validating Safety Tables using SAS and ensuring the validation of ADaM and derived datasets will also be part of your responsibilities. Furthermore, you will be involved in validating SDTM datasets and their specifications while adhering to the required training...