5 Cdisc Sdtm Jobs

Key Responsibilities Develop and maintain R programs for generating CDISC SDTM and ADaM datasets and tables, listings, and figures in accordance with clinical trial data requirements Ensure compliance with industry standards and regulatory requirements Collaborate with cross-functional teams to understand and implement project-specific data needs Provide technical expertise and support for data analysis and reporting tasks Perform quality control and validation of outputs to ensure accuracy and consistency Qualifications Bachelor&aposs degree in a quantitative field (e.g., Statistics, Mathematics, Computer Science, Data Science) Minimum of 3 years of experience in R programming including familiarity with R packages used in the analysis and reporting of data for clinical trials Familiarity with data visualization techniques and tools in R Experience with clinical trial data and familiarity with CDISC ADaM and SDTM standards Strong analytical and problem-solving skills Excellent communication and ability to work in a team environment Desirable Skills Knowledge of other open-source packages and tools Experience with SAS software Familiarity with CRAN, POSIT, and other open-source repositories and products Learn more about our EEO & Accommodations request here. Show more Show less

As a qualified candidate for the position, you will be responsible for utilizing your strong SAS data manipulation, analysis, and reporting skills, along with a robust output programming experience. Your expertise in implementing the latest CDISC SDTM/ADaM standards will be essential for this role. Additionally, your familiarity with the drug development life cycle and experience in manipulating, analyzing, and reporting clinical trials data will be crucial. Your primary responsibilities will include the development and execution of statistical analysis and reporting deliverables, such as safety and efficacy analysis datasets, tables, listings, and figures. You will also be expected to develop and review SAS programs for data analysis, tables, figures, and listings to ensure the accuracy and consistency of data output. To be considered for this role, you must hold a Bachelors or Masters degree in a data science field, such as statistics, mathematics, computer science, or bioinformatics. A minimum of 4 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry is required. You should also possess strong expertise in SAS programming, as well as proficiency in other statistical software such as R and Python. This position is based onsite in Noida, Uttar Pradesh.,

Company Description CPVIA Private Limited is a clinical data analytics solutions company offering statistical programming outsourcing and statistical consulting services. Our mission is to help customers accelerate drug development activities across therapeutic areas with increased quality and optimum cost through our experienced and expert team. We provide specialized services including CDISC Data Standardization, Statistical programming, and biostatistics consultancy. We serve pharmaceutical, biotechnology, and medical device companies. Role Description This role is for Senior & Principal Statistical Programmers located in Hyderabad . The role involves performing day-to-day statistical programming tasks, supporting clinical data management, developing and maintaining macros, and contributing to statistical data analysis. Responsibilities also include but not limited to: Writing and validating complex statistical programs, maintaining data integrity, and ensuring compliance with regulatory requirements. Strong experience with CDISC SDTM and ADaM standards with solid understanding of GCP, ICH guidelines, and regulatory submission requirements. Extensive experience with SDTM, ADaM and TFL programming using SAS (and optionally R) . Provide technical leadership and oversight to fellow programmers. Contribute to create and develop macros, utilities and automation tools for reuse across projects. Should be flexible and available to work in overlapping US and/or UK business hours . Qualifications Minimum 6+ years (for Sr.)/ 10+ years (for Principal) expertise in Statistical Programming in Clinical Research. Bachelor&aposs or Masters degree in Statistics, Biostatistics, Life Sciences, Computer Science, or a related field. Strong understanding of Statistics and Data Management activities. Experience in developing and maintaining Macros. Excellent written and verbal communication skills. Ability to work collaboratively in a team-oriented environment. How to Apply: If you are eligible with the above requirements, please send your CVs to [HIDDEN TEXT] Show more Show less

You will be responsible for providing statistical programming support to clinical trials at Statistics & Data Corporation (SDC), a specialized contract research organization headquartered in Arizona. Since 2005, SDC has been delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies. As part of a technology-enabled service offering, you will contribute to both clinical services expertise and technological support required for successful clinical trials. Your primary responsibilities will include performing all statistical programming necessary for clinical trial analysis and reporting. You will apply appropriate statistical methods for data analysis, review Statistical Analysis Plans, and design/develop SAS macros and utilities to streamline programming activities. Additionally, you will generate tables, listings, and figures per protocol and client requests, participate in program validation and quality control activities, and develop SDTM and ADaM datasets. You will collaborate with various departments such as Clinical Operations, Project Management, and Data Management to ensure high client satisfaction through successful project execution. Your role will also involve mentoring junior statistical programmers, maintaining project files, adhering to quality systems, and complying with data integrity and business ethics requirements. To be successful in this role, you must possess strong analytical skills, proficiency in SAS programming (including SAS/Base, SAS/Stat, and SAS Macros), and a basic understanding of SAS/Graph. You should have a solid grasp of statistical programming, the ability to identify and resolve data issues, and excellent communication skills to convey technical concepts clearly to non-statistical colleagues. Familiarity with clinical trial design, regulatory guidelines, and CDISC SDTM and ADaM data models is essential. Ideally, you should hold a Bachelor's degree in computer science, statistics, or a related scientific field, along with four years of relevant professional experience. SDC offers a supportive work environment that values employee development, growth opportunities, career advancement, flexible work schedules, an engaging culture, and various benefits. Join SDC's dynamic team and contribute to the successful execution of client clinical programs while being part of a company that fosters innovation, growth, and a sense of belonging among its employees.,

As a Statistical Programmer at Statistics & Data Corporation (SDC), a reputable contract research organization based in Arizona, you will be responsible for providing statistical programming support for clinical trials. Your primary role will involve producing statistical analyses, generating and validating analysis datasets, tables, listings, and figures for clinical trials. You will be required to create SDTM mapping and datasets, develop and maintain project files of SAS datasets and SAS code, and support Data Management in various data-related tasks. Additionally, you will act as a liaison between clinical subcommittees and project teams as needed. Your responsibilities will include overseeing statistical programming activities for medium to large-scale projects, applying appropriate statistical methods for data analysis, and providing statistical programming expertise to project teams. You will review the Statistical Analysis Plan, lead the development of SAS macros and utilities, and conduct internal training sessions. Furthermore, you will be responsible for generating tables, listings, and figures as per protocol requirements, participating in statistical program validation activities, and developing SDTM and ADaM datasets. You will also ensure compliance with CDISC and FDA guidelines, develop define.xml and study data reviewer's guides, and communicate effectively with project teams and management. In addition to the technical aspects of the role, you will play a key role in mentoring junior statistical programmers, managing programming timelines and budgets, and ensuring adherence to SDC's standard procedures and quality system. Strong analytical and problem-solving skills, proficiency in SAS programming, and knowledge of regulatory guidelines are essential for this position. To qualify for this role, you should possess a Bachelor's degree in computer science, statistics, or a related scientific field, along with at least six years of relevant professional experience. Certification in SAS Base, Advance, and Clinical Trials is preferred. At SDC, we are committed to the growth and development of our employees, providing a flexible work schedule, engaging work culture, and career advancement opportunities. Our company culture is centered around core values such as Energy, Integrity, Engagement, and Innovation. Join our team and be part of a dynamic and innovative organization that is dedicated to supporting both our clients and employees in this ever-evolving industry.,