31 Cdisc Standards Jobs

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...

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. - Providing data mapping leadership across assigned use cases - Managing task allocation for Clinical Data Mapper staff - Resolving...

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 Statistical Programmer in our clinical research team, you will have the crucial responsibility of programming, validating, and delivering statistical outputs for clinical trials. Your role will involve ensuring compliance with regulatory standards and industry best practices. Key Responsibilities: - Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting - Map clinical trial data to CDISC standards (SDTM and ADaM) to ensure regulatory compliance - Create and maintain analysis datasets following CDISC implementation guidelines - Perform data validation and quality control checks to uphold data integrity - Generate and maintain CDISC documentation inc...

Role Overview: Lead and oversee application development projects, providing technical expertise to build innovative data analysis and visualization solutions for clinical research. Core Responsibilities: Design, develop, test, and optimize R Shiny/Python web apps; ensure compliance with ICON standards and regulatory requirements; mentor junior programmers; manage resources and timelines. Technical Expertise: Advanced skills in R, R Shiny, SAS, tidyverse, R Markdown, relational databases, and CDISC standards; proven experience in scalable app design and deployment. Experience Required: 6+ years of programming (3+ in R & R Shiny) within pharma/clinical trial data environments, with expertise i...

Senior level associate with 8+ yrs of experience Skills: R and R shiny programming experience is mandatory; SAS experience is optional , Python good to have, experience on at least 1 compete study is great add on. The candidate should be experienced in applying these skills in analysis and reporting of clinical trials and being able to reproduce statistical analysis using R. Data visualization, data wrangling using R will be important skills to have. Knowledge of R packages and their application, Data exploration using R Shiny apps and application of statistical methodology / concepts will be a huge plus. Strong understanding of phases of clinical trials and the drug development process. Kno...

Role Overview: As a Lead Statistical Programmer, you will be responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role will involve 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 Efficacy...

Role Overview: As a Lead Statistical Programmer in the clinical data field, you will be responsible for overseeing programming activities related to clinical trials, regulatory submissions, and integrated analyses. Your role will involve leading a team, ensuring the delivery of high-quality work, and establishing 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 Saf...

Role Overview: As a Statistical Programmer II at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model prioritizes putting the customer and patient at the center of our work, aiming to simplify processes and innovate as a team to make a difference in people's lives. Key Responsibilities: - Utilize advanced proficiency in Base SAS, SAS Macro, and SAS SQL for clinical trial data analysis and reporting - Demonstrate in-depth knowledge of CDISC standards to develop ADaM specifications and datasets for regulatory submissions - Produce high-quality Tables, Listings, and Figur...

Phastar is a globally recognized biometric Contract Research Organization (CRO) that partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality biostatistics, programming, data management, and data science services. Accredited for excellence by Best Companies, Phastar is dedicated to fostering a rewarding work environment and is committed to ensuring employee engagement, workplace satisfaction, and a healthy work-life balance. With a presence in multiple countries worldwide, Phastar stands as a leader in specialized biometrics, emphasizing quality and technical expertise as its key values. As a clinical programmer with a strong background in SAS and R p...

As a Principal Statistical Programmer at TalentSurabhi (TS), you will be playing a key role in our start-up firm dedicated to shaping the evolving landscape of the Indian recruitment industry through in-depth talent pool analytics. Your primary responsibility will involve statistical programming, proficient data management, and the creation of macros to facilitate data analysis and interpretation. We are seeking a candidate with a strong foundation in statistical programming, a blend of statistical and programming expertise, adept data management capabilities, and the proficiency to develop macros for enhanced data analysis. Your role will require solid analytical and problem-solving skills,...

The Associate Director Biostatistics position based in Ahmedabad requires a candidate with an MSc or PhD in Biostatistics/Statistics and at least 12 years of experience in CROs, Bio-tech, Pharma, or Biopharmaceuticals. As an Associate Director Biostatistics, your main responsibilities will include leading and overseeing all statistical activities for clinical studies. This involves tasks such as study design, analysis plans, reporting, and publications. You will be managing a team of statisticians and programmers to ensure the timely delivery of high-quality work. Additionally, you will provide statistical input on protocols, sample size calculations, and randomization schemes, as well as de...

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. As a Manager in Clinical Data & Technology within Life Sciences Consulting at EY, you will be part of our Life Sciences sector team, assisting clients in reimagining their clinical data strategies and implementing cutting-edge solutions across trial data capture, management, and analytics. You will play a strategic role in shaping next-gener...

Job Summary: Serve as a technical subject matter expert (SME) for CDISC and other industry and regulatory standards. Contribute to the development of standardized programming tools, macros, and SOPs for efficiency and compliance. Lead multiple complex and/or global clinical trial programming projects, mentoring and guiding statistical programming teams. Ensure compliance of programming deliverables with CDISC standards, regulatory requirements, and internal guidelines. Key Responsibilities: Collaborate with biostatistics and programming teams to establish SOPs, guidelines, policies, and procedures. Develop and optimize programming tools and macros for standardization and efficiency. Serve as...

Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as...

We are seeking a Principal Biostatistician with a strong background in efficacy analysis to join our team. The ideal candidate will have extensive experience in creating and validating CDISC-compliant datasets , developing statistical analysis plans, and producing high-quality mock tables, listings, and figures. This role requires a detail-oriented professional with excellent communication skills who can manage multiple projects and collaborate effectively with cross-functional teams. Must-Have Skills Hands-on experience with efficacy analysis. Ability to manage multiple projects and meet tight deadlines. Excellent communication and collaboration skills. Good to Have Skills Proficiency in CD...

As a Biostatistician at our organization, you will play a crucial role in contributing to cross-functional development teams, aiding in trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your responsibilities will involve collaborating with various team members including the Global Biometric Sciences Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other study/indication team members. Your role will require you to provide strategic and scientific input at the indication/protocol/integrated analysis level, thereby enhancing the understanding of the asset under study, improving devel...

You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves develop...

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data manageme...

The Senior/Principal Clinical Database Manager is responsible for the design, development, testing, implementation, maintenance, and support of clinical databases and applications. You will interface directly with the internal team, EDC vendor, clients, and third-party vendors to gather requirements and provide status updates. Providing operational and technical training to end users and junior staff is a key aspect of this role. Additionally, you may play a lead role in internal software projects that require specialized programming and/or scripting. To be considered for this position, you must have experience in developing and customizing clinical data management databases in a clinical, s...

The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related ...

We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment wi...

As a Senior SAS Programmer at our rapidly growing corporate activities in India, Mumbai, you will play a crucial role in our Biostatistics team. You will have the opportunity to work alongside a dedicated team to complete tasks and projects essential for the company's success. If you are looking for a challenging career where you can utilize your expertise and further develop your skills, this position offers an exciting opportunity for professional growth. Your responsibilities will include proposing and developing specifications for new projects, leading project teams, and writing SAS programs to create analysis datasets, tables, listings, and figures. You will be responsible for programmi...

The ideal candidate for the Biostatistician role should possess a Master's degree in Statistics or equivalent. A Ph.D. in Statistics or equivalent combined with 6 years of industry-related experience is also a preferred qualification. With at least 9+ years of experience, the candidate must demonstrate a deep understanding of statistical and clinical trials methodology as it pertains to clinical development. As a Biostatistician, you will be an integral part of cross-functional development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your role will involve collaborating with various stakeho...

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user req...