85 Cdisc Standards Jobs - Page 2

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...

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 Principal 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: This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instru...

Role Overview: As a Senior Statistical Programmer working fully embedded within a pharmaceutical client, supported by Cytel, you will play a crucial role in driving innovation and supporting global pharmaceutical clients in driving the next generation of patient treatment. You will have the opportunity to work autonomously and take ownership in a dynamic environment. Key Responsibilities: - Perform data manipulation, analysis, and reporting of clinical trial data using SAS programming - Generate and validate SDTM and ADaM datasets/analysis files, as well as tables, listings, and figures (TLFs) - Conduct production and QC/validation programming - Generate complex ad-hoc reports from raw data ...

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...

Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Designer to join our Biometrics team. This position will work in 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. Responsibilities Maintain eCRF and Edit Check Specification standard templates according to CDISC standards for data collection and data submission; Develop and maintain eCRF specifications on a study-by-study basis (e.g., reviewing protocol and customize library eCRFs to ...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. Allucent (India) Pvt. Ltd. is seeking an experienced Sr. Clinical Programmer I to join the team. The Senior Clinical Programmer I develops and coordinates clinical programming activities, maintains clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards and regulatory requirements. He/She will provides expertise in relevant clinical programming areas and cross-...

Senior Statistical Programmer - India 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. We are currently seeking a Senior Statistical Programmer I to join our diverse and dynamic team. As a Senior Statistical Programmer I at ICON, you will play a crucial role in analyzing clinical trial data and supporting the statistical analysis process to ensure high-quality results. You will contribute to the success of our clinical studies by developing and validating statistical programs, collabo...

HOW MIGHT YOU DEFY IMAGINATION If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, 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. Senior Director Global Statistical Programming What You Will Do Let's do this. Let's change the world. Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated d...

KEY TASKS & RESPONSIBILITIES Acts as the key scientific and technical data management expert; define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting Manage the data management delivery team and develop the capability for the group to support the existing workload while building expanding the capability as necessary to support the growth of the organization Ensure Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable eClinical Solutions ...

Bachelor's degree from reputable university preferably in science/ mathematics related fields Preferred SAS certification Technical Skills Requirements Must have expertise of SAS Base, and good knowledge of SAS graph and SAS Macros. Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. Must have excellent knowledge of CDISC standards (SDTM and ADaM) Thorough understanding of relational database components and theory. Excellent application development skills. Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. Good understanding of ICH E6, ICH E3, ICH E8,...

TCS is hiring Statistical Programmer Skill - Statistical Programmer Job Location PAN India 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 generating TLFs, programming ...

Role Overview: You are an experienced Lead Statistical Programmer responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficac...

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...

Premier Research is looking for a Director, Biostatistical Programming to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovati...

Job Title: Statistical Programmer Location : Mumbai / Pune / Bangalore Experience : 3 - 7 years Industry : Pharmaceuticals / Biotechnology / Clinical Research About the Role We are looking for an experienced Lead Statistical Programmer to oversee programming activities for clinical trials, regulatory submissions, and integrated analyses. This role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities Lead statistical programming activities for a compound or therapeutic area. Manage, mentor, and guide a team of statistical programmers. Create and validate analysis data sets (ADaM), tables, ...

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 Principal 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 This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept...

As a Biostatistician at the company, you will play a vital role in cross-functional development teams by contributing to various aspects of trial design, protocol development, analysis planning, interpretation of results, and regulatory submissions. Your main responsibilities will include: - Developing collaborative relationships with team members such as the GBDS Biostatistics Lead, medical monitor, protocol manager, data manager, and PK scientist. - Making strategic and scientific contributions at the indication/protocol/integrated analysis level to enhance understanding of the asset being studied. - Driving the selection of optimal study designs, data collection methods, analytic approach...

As a Senior Clinical Data Associate at our company, you will play a crucial role in providing support and assistance throughout the clinical trial data management process for assigned projects. Your responsibilities will include: - Supporting the Lead DM as a back-up or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies when necessary - Conducting quality control of data entry - Providing input into timelines and assessing resource needs for projects - Developing CRF specifications and coordinating feedback from stakeholders - Assisting in building clinical databases and conducting database build UAT - Specifying requirements for variou...

Role Overview: You will provide expertise under the Global Head, Statistical Programming in AQS Development, focusing on quality, CDISC standards, open-source capabilities, automation, and data structures for modeling. This role requires extensive experience in drug development, GCP, and regulatory requirements. You will enhance open-source programming capabilities and programming/reporting standards across therapeutic areas, acting as an influential leader representing Statistical Programming at leadership meetings, overseeing and coordinating all functional activities, and collaborating to ensure consistency in programming practices across sub-functions. Your initiatives will lead to estab...

Role Overview: As a Senior SAS Programmer at the rapidly growing corporate office in India, Mumbai, you will play a vital role in the Biostatistics team. Your primary responsibility will be to propose and develop specifications for new projects, lead project teams, and write SAS programs for creating analysis datasets, tables, listings, and figures. Your expertise in SAS programming and adherence to CDISC standards will be crucial for the success of projects. Key Responsibilities: - Propose and develop specifications for new projects and lead project teams - Write SAS programs for creating analysis datasets, tables, listings, and figures - Program, validate, and maintain mapped databases usi...

As a Senior Clinical Data Associate at [Company], you will be responsible for providing data management support and assistance throughout the clinical trial data management process. Your role will involve following Standard Operating Procedures (SOPs) and regulatory directives to ensure the successful completion of assigned projects. Some key responsibilities include: - Supporting the Lead DM as a back-up and/or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies and conducting quality control of data entry - Assisting in developing CRF specifications and coordinating the review/feedback from stakeholders - Building clinical databases an...

R Developer Pan India | Remote allowed. Work Hours: 12 PM - 9:00 PM IST (with US overlap) for meetings with Onsite Leadership Job Summary: Developer role for the migration of statistical programming assets from SAS to R, supporting clinical trial data analysis and reporting. Suitable for professionals with solid experience in hands-on R and R Shiny development. Life sciences Biostatistics experience is good to have. Key Responsibilities: Translate and optimize SAS code into efficient R scripts. Develop and maintain R Shiny applications for data visualization and reporting. Perform statistical analyses for clinical trial data using R. Provide technical guidance to junior team members. Ensure ...

Job Title: Senior Statistical Programmer Introduction To Role Do you have a passion for programming Are you an expert in your field Would you like to apply your skills to impact the drug development process and regulatory interactions in a company that follows the science and turns ideas into life-enhancing medicines Then AstraZeneca might be the one for you! Join our team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules in all stages of our innovative pipeline, we keep pushing forward to conquer cancer through data, innovation, and evidence-based decisions. Accountabilities As a Senior Statistical Programme...

Role Overview: At EY, you will have the opportunity to shape a unique career tailored to your strengths, with the necessary global support, inclusive environment, and advanced technology to help you reach your full potential. Your distinct voice and perspective are crucial in contributing to EY's continuous improvement. By joining us, you will not only create a remarkable experience for yourself but also contribute to building a better working world for all. Key Responsibilities: - Drive consulting engagements focused on clinical data transformation, including SDTM mapping, CDASH adoption, and standards harmonization. - Lead client workshops, diagnostic assessments, and solution design initi...

**This is a Contract job for 3 months with possible extensions** Primary Purpose The Senior Statistical Programmer provides lead statistical programming support for multiple clinical projects using SAS and provides expert consultation across the company. Key responsibilities include delivering key regulatory-compliant output, developing programming documentation, writing efficient code, staying updated on programming techniques, and mentoring staff. The role also includes providing project updates to management while performing assigned duties and presents internally on statistical programming topics. Responsibilities Provides lead statistical programming support for multiple clinical resear...