619 Sdtm Jobs - Page 9

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. Technical Architect – Life Sciences R&D (Manager Level) Experience: 10+ Years Employment Type: Full-Time Role Overview As a senior Technical Architect, you will drive the design and implementation of robust and scalable architecture across data ingestion (L1), integration (L2), and consumption (L3) layers for life sciences R&D. You will colla...

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Data Engineer – Life Sciences R&D (Senior Level) Experience: 8+ Years Role Overview As a senior Data Engineer, you will be responsible for building robust, scalable, and compliant data pipelines from raw scientific sources to integrated and consumption-ready data products in the R&D landscape. You will partner with architects, domain SMEs, and analysts to develop re-usable components supporting early discovery, development, and regulatory needs. Key Responsibiliti...

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Data Engineer – Life Sciences R&D (Senior Level) Experience: 8+ Years Role Overview As a senior Data Engineer, you will be responsible for building robust, scalable, and compliant data pipelines from raw scientific sources to integrated and consumption-ready data products in the R&D landscape. You will partner with architects, domain SMEs, and analysts to develop re-usable components supporting early discovery, development, and regulatory needs. Key Responsibiliti...

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. Technical Architect – Life Sciences R&D (Manager Level) Experience: 10+ Years Employment Type: Full-Time Role Overview As a senior Technical Architect, you will drive the design and implementation of robust and scalable architecture across data ingestion (L1), integration (L2), and consumption (L3) layers for life sciences R&D. You will colla...

Description Manager Statistical Programming Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, inno...

Main responsibilities: The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for analysis datasets and provide QC done data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable; The Principal Biostatistician will ensure SOPs are f...

Minimum experience: 10 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor wed love to connect!

Main responsibilities: The Senior Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Global Hub biostatistics and programming personnel to implement (Develop and/or QC) statistical analysis plans(SAP), programming specifications for analysis datasets and provide QCd data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable) .The Senior Biostatistician will ensure SOPs a...

Grade: L2-2 About the job 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 practices for metadata management across global and study-specific levels. Understand the CDISC models (CDASH, SDTM, External Data, Controlled Terminology) and all regulatory requirements regarding Data Standards. Actively leads Therapeutic Area Working Groups. The Principal Data Standards Analyst will bridge the gaps between global metadata strategy and its adoption withi...

Sponsor-dedicated: 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 trials. This ...

Description Director, AI Solutions Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE M...

We are seeking a highly skilled Lead Statistical Programmer with expertise in SAS and R programming to support clinical trial data analysis and regulatory submissions. The ideal candidate will author and validate programs, manage client projects, and ensure compliance with CDISC standards and regulatory requirements. Key Responsibilities: Author, validate, and document SAS programs for datasets, TFLs, and macros, applying good programming practices. Develop and maintain programs in R , with hands-on experience in packages such as Tidyverse, Admiral, Create ADaM datasets using Admiral packages in R. Read and write raw data across SAS and R platforms. Conduct thorough debugging using R console...

Description Director, AI Solutions Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE M...

Role Overview: As a Statistical Programmer II at Princeps Technologies in Hyderabad, you play a crucial role in the organization's data-driven approach to advanced analytics and technology solutions for the pharmaceutical and biotechnology industries. Your focus will be on developing and validating SDTM datasets, creating ADaM datasets, and programming Tables, Listings, and Figures (TLFs) to meet sponsor requirements. Additionally, you will generate subject narratives, produce clinical registry files, perform quality control on programming deliverables, and prepare electronic submission packages in compliance with global regulatory standards. Key Responsibilities: - Develop and validate SDTM...

As a Data Standards Specialist at ICON plc, you will be responsible for creating and maintaining content in the Data Standards Catalog. You will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your role will involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Additionally, you will actively participate in governance team meetings and provide input on assigned standards. You will work closely with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy and ensure compl...

The ideal candidate for the Senior Statistical Programming position should have a minimum of 3-8 years of experience. You should possess a strong understanding of SAS Base/Macros/GTL and have hands-on experience in SDTM/ADAM/TLFs creation following CDISC standards. Your expertise should lie in both Base and Advance SAS programming. You will be responsible for developing complex SAS macros that can be applied across Therapeutic Areas in various studies. Additionally, your role will involve reviewing the SAS programs that have been developed. Proficiency in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components is crucial for this position. As a Senior Statistical Programm...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Technology Product & Platform Management Job Sub Function: Functional Engineering Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Kar...

Title : PYTHON AI ENGINEER - Automated Test Data Generation Location: Remote (India) Timing: 06:30 PM to 03:30 PM IST Overview We are seeking a Python AI Engineer with expertise in synthetic and automated test data generation to support clinical trials, regulatory submissions, and GxP-compliant systems across the life sciences domain. This role will focus on building intelligent frameworks that generate high-quality, audit-ready datasets for use in clinical data management (CDM), biostatistics, pharmacovigilance, and regulatory validation environments. By leveraging AI/ML techniques and Python-based automation, this role will help reduce dependency on production data, accelerate testing cycl...

Your Role We are seeking an experienced and collaborative Senior Statistician I to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory compliance of statistical deliverables. The Senior Statistician will also oversee quality control processes and contribute to the development of statistical analysis plans and datasets. In this role, you will: Provide statistical leadership and support for clinical trials, ensuring high-quality deliverables. Participate in cross-functional stu...

As a Statistical Programmer, your role involves performing, planning, coordinating, and implementing various tasks for complex studies. This includes programming, testing, and documenting statistical programs for creating statistical tables, figures, and listings. Additionally, you will be responsible for programming analysis datasets and transfer files for both internal and external clients. Ensuring programming quality control checks for source data and reporting data issues periodically is also a key part of your responsibilities. Key Responsibilities: - Interpret project level requirements and develop programming specifications for complex studies - Provide advanced technical expertise t...

Role Overview: You are being offered the opportunity to join as an Associate Director, PKPD / Pharmacometrics / NONMEM / SAS Programmer in the Clinical Pharmacology and Quantitative Pharmacology Data Programming team. Your main responsibility will be to prepare, program, validate, and diagnose data to support Pharmacometrics and Clinical Pharmacology analyses. Your influence will be vital in shaping crucial decision-making processes throughout all stages of drug development and regulatory interactions. Key Responsibilities: - Expertly clean, manipulate, transform, and integrate data at both the study and compound level to ensure accurate analysis. - Utilize advanced data integration techniqu...

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 ...