84 Cdisc Standards Jobs

Description Principal Statistical Programmer(SDTM)- Hybrid (Hyderabad /Gurugram) 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. 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, you'll collab...

Description Principal Stat Programmer(ADAM & TLF) 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. 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, you'll collaborate with passionate problem s...

About Tech Observer Tech Observer is a global Contract Research Organization (CRO) providing end-to-end clinical research solutions to pharmaceutical, biotechnology, and medical device companies, including flexible FSP (Functional Service Provider) solutions . Headquartered in New Jersey, USA, Tech Observer operates across the USA, EMEA, and APAC regions, with an established presence in the UK, India, Singapore, Denmark , and 20+ countries worldwide . Job Location: Ahmedabad/Mumbai/Hyderabad/Noida Key Responsibilities Statistical Programming Ensure compliance with applicable SOPs , the Quality Management System (QMS) , and Good Clinical Practice (GCP) . Implement and adhere to the latest ver...

Role Overview: As a Clinical Database Designer/eCRF Specialist at Capgemini, you will be responsible for designing and maintaining clinical study databases to ensure accurate data collection and compliance with global standards. Working independently and collaborating with cross-functional teams, you will deliver robust technical solutions for complex trials. Your role will involve designing study databases and eCRFs per protocol in Medidata Rave, maintaining clinical databases post-production, developing and updating study setup Gantt charts, configuring customer-specific solutions, managing technical documentation, and analyzing customer requirements to propose technical solutions. Key Res...

As a Senior SAS Programmer at our rapidly growing corporate office in Mumbai, India, you will be an integral part of the Biostatistics team. Your role will involve proposing and developing specifications for new projects, serving as a project team leader, and writing SAS programs for creating analysis datasets, tables, listings, and figures. You will also be responsible for programming edit checks for external data, validating and maintaining mapped databases using SAS, and ensuring the setup, validation, and maintenance of mapped databases. Your expertise will play a crucial role in the company's success, providing you with the opportunity to further develop and grow your career. **Key Resp...

Job Title - Statistical Programmer/ Sr Statistical Programmer Location - Bangalore, Karnataka(Hybrid) Job Description : Minimum 4+ years of experience in statistical programming within a clinical trial environment. Proven experience with SDTM and ADaM dataset creation. Strong experience in generating safety and efficacy TLFs (tables, listings, figures). Technical Skills: Proficiency in R programming for statistical analysis and reporting. Solid understanding of CDISC standards (SDTM, ADaM). Familiarity with clinical trial data management systems (e.g., CDMS, clinical trial software). Soft Skills: Strong attention to detail and ability to manage multiple tasks. Excellent communication and col...

Job Description Medidata Rave Location: Pune Experience: 6yrs 9yrs Choosing Capgemini means choosing a place where you'll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what's possible. Join us in helping leading healthcare and life sciences organizations deliver clinical trials efficiently and compliantly across the globe. Your Role As a Clinical Database Designer/eCRF Specialist at Capgemini, you will design and maintain clinical study databases that ensure accurate data collection and compliance with global standards. You'll work independently and collaborate with cross-functional teams to deliver robust technical solutions for ...

Description Principal Statistical Programmer(SDTM,ADAMS,TLF)-Hybrid-Hyderabad & Gurugram 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. 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, you'l...

Description Senior Statistical Programmer- Hybrid (Hyderabad & Gurugram) 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. 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, you'll collaborate wi...

Description Principal stat programmer - Immediate Joiners 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. 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, you'll collaborate with passionate p...

HOW MIGHT YOU DEFY IMAGINATION If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Biostatistics Sr Associate What You Will Do Let's do this. Let's change the world. Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership...

Description Sr Biostatistician-RWE 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. 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, you'll collaborate with passionate problem solvers, innovat...

Description Principal Statistical Programmer(SDTM,ADAMS,TLF)-Hybrid-Hyderabad & Gurugram 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. 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, you'l...

Role Overview: As a Senior Director Global Statistical Programming at Amgen, you will play a vital role in expanding the global Statistical Programming capabilities, with a focus on supporting integrated delivery across regions. Your leadership will be crucial in providing local functional support from Amgen India (AIN) to global clinical development programs, ensuring seamless execution, quality deliverables, operational excellence, and regulatory compliance through the utilization of digital innovation. Key Responsibilities: - Provide strategic and operational leadership for statistical programming delivery within Amgen's global framework, with site accountability based in AIN. - Oversee t...

Description Senior Statistical Programmer- Hybrid (Hyderabad & Gurugram) 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. 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, you'll collaborate wi...

TCS is hiring Statistical Programmer! Skill - Statistical Programmer Job Location Mumbai, Pune, Bangalore/Noida Experience Range 3 to 12 Years Educational Qualification(s) Required Graduate/Postgraduate ( Any life-science/ Engineering ) Required Skillsets: Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses Proficiency in using statistical software and programming tools Familiarity with clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation. Knowledge of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.) Experience in generati...

As a Data Standards Specialist at ICON, your role will involve 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 responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Additionally, you may serve as a subject matter expert (SME) for specific topics. Key Responsibilities: - Create and maintain content in the Data St...

Role Overview: As a Clinical Data Operations Specialist at Novartis Healthcare Private Limited, your role is crucial in managing data operations for use cases and demand deliverables within the Clinical Pipeline team. You will be responsible for overseeing the timely and professional maintenance of the clinical data warehouse, ensuring cost-effectiveness, quality, and adherence to timelines. Your involvement will extend to developing engaging training modules for Clinical Data Mapper onboarding, utilizing AI-based technology to simplify processes and enhance training delivery. Key Responsibilities: - Provide data mapping leadership across assigned use cases. - Manage task allocation for Clin...

Role Overview: As a member of the Pharmaceutical & Life Sciences team, your role will involve overseeing the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, as well as supporting and facilitating the review of medical coding for validity and completeness. Your key focus will be on ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. It will be essential for you to maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock. Additionally, staying updated on industry best pr...

Description Make an Impact in Global Clinical Programming Are you an experienced statistical programmer looking to take the next step in your career We're expanding our team in India and are seeking skilled SAS programmers who are confident working with clinical trial data and CDISC standards. In this role, you'll have the chance to take ownership of your work, support junior team members, and contribute to high-quality analysis that drives important decisions in global clinical research. If you enjoy solving complex data challenges, collaborating with a supportive team, and stepping into responsibilities that help you grow, we'd love to hear from you. What You'll Do Use your SAS programming...

Role Overview: You will be working as a Manager, Innovation Strategy and Solutions Lead at Bristol Myers Squibb, where you will support the framing, assessment, recommendation, and implementation of innovative strategies and solutions to enhance efficiencies and automation in the clinical development process. Your focus will be on modernizing processes and technology implementation to enable end-to-end solutioning and transformation. Key Responsibilities: - Support the framing, assessment, and prioritization of internal and external innovation initiatives to enhance efficiency and quality across clinical development activities. - Apply expertise in R programming, including Shiny dashboards a...

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work...

Key Responsibilities Develop, validate, and maintain ADaM datasets , TLFs , and other analytical outputs for clinical trials. Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables. Contribute to ISS/ISE activities , including dataset integration, analysis, and documentation. Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery. Assist in regulatory submissions and RTQs , providing clear, traceable, and compliant programming outputs. Collaborate in an agile environment , participating in sprint meetings, planning, and continuous improvement discussions. Work with internal tools ...

As the Lead Data Manager, your role involves overseeing end-to-end clinical data management activities for multiple trials to ensure data integrity, protocol compliance, and timely database deliverables. You will provide technical leadership, manage data systems and processes, and collaborate with study teams throughout the study lifecycle. Key Responsibilities: - Execute and oversee data management activities for multiple clinical trials, ensuring accuracy and alignment with protocols and EDC systems. - Apply advanced understanding of clinical development, CDISC standards (CDASH, SDTM), technical platforms, confidentiality protocols, and project management principles. - Contribute to trial ...

Grade: Manager Location: Hybrid at Gurugram/Mumbai. 100% Remote for the right candidate. Job Purpose Lead one or more Phase I-IV studies programming activities as per the project strategies. Work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in a timely manner with high quality. Participate in and contribute to development of standard macros, libraries, processes and act as a team p...