271 Cdisc Jobs - Page 8

Key Responsibilities: Statistical Support: Provide statistical support to clinical studies. Data Review: Review analysis datasets and efficacy tables, listings, and figures (TLFs). Statistical Analysis: Perform statistical analyses and interpret results. Report Preparation: Prepare clinical study reports, including integrated summaries for submissions. Communication: Present and explain methodology and the consequences of decisions in lay terms. Team Collaboration: Serve as a team player, showing adaptability and flexibility when priorities change, and going the extra distance to achieve results and meet deadlines. Required Knowledge, Skills, and Abilities: Communication Skills: Excellent wr...

rimary Responsibilities Data Provision to Clients Create and execute SAS edit check programs . Validate edit check programs using standard validation practices and processes. Develop SAS programs to convert data from EDC systems to protocol-specific SAS datasets according to customer specifications. Assist in the creation of SAS-related project programming and validation documentation. Develop SAS macro and format libraries. Data Quality Assurance Review and approve User Requirement Specifications (URS) , Clinical Data Management (CDM) conventions, and related documents. Develop and implement new CDM systems or enhancements to current systems. Ensure the creation of CDISC-compliant datasets ...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers, and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing i...

You should have 4-6 years of experience in Real-World Data Analysis and hold a Masters/PhD in Statistics, M.Tech, or M.Pharma. Your expertise should include a strong foundation in large database analysis, biostatistics, clinical trial, observational research, and epidemiology. You must be able to handle large databases such as administrative claims, electronic health records, and patient chart review. Additionally, you should possess the ability to manage multiple projects and deliver results within tight timelines while demonstrating excellent interpersonal skills and analytical thinking. In terms of tools and platforms, you should be proficient in healthcare coding systems like ICD9 and 10...

As a Data Management Specialist, you will be responsible for designing and reviewing Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. You will develop and maintain Data Management Plans (DMPs), data validation specifications, edit checks, and coding guidelines. Your role will involve overseeing data entry, data cleaning, discrepancy management, and query resolution processes to ensure data integrity. It will be your responsibility to ensure compliance with industry standards such as CDISC (CDASH, SDTM) and regulatory guidelines from FDA and ICH-GCP. You will be involved in conducting User Acceptance Testing (UAT) of EDC systems and monitoring data quality throughout the pr...

At ZS, passion changes lives. ZS is a management consulting and technology firm dedicated to enhancing lives and how we lead them. The company's most valuable asset is its people. Working at ZS means collaborating with a dynamic group of thinkers and experts who are developing groundbreaking solutions for patients, caregivers, and consumers globally. ZSers make an impact by adopting a client-first approach to every project. Through collaborative partnerships with clients, ZS creates tailored solutions and technology products that drive value and deliver tangible results in key areas of their operations. If you bring a thirst for learning, innovative ideas, courage, and a drive to make a sign...

Summary Provide highly advanced expert support & functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative...

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas su...

The ideal candidate for this position should have a solid background in real-world data analysis with at least 4-6 years of experience. A Master's or PhD in statistics, M.Tech, or M.Pharma is required. You should possess a strong foundation in large database analysis, biostatistics, clinical trial, observational research, and epidemiology. Experience in handling large databases such as administrative claims, electronic health records, and patient chart review is crucial. You must have the ability to manage multiple projects effectively and deliver results within tight deadlines. Strong interpersonal skills and analytical thinking are essential for this role. In terms of tools and platforms, ...

Skills & Qualifications Exp - 4-6 years in Real world data analysis Qualification - Masters/PhD in statistics, M. Tech, M. Pharma Strong foundation in large database analysis, biostatistics, clinical trial, observational research and epidemiology Experience with handling large databases like administrative claims, electronic health records, patient chart review, Ability to manage multiple projects and deliver results under tight timelines Excellent interpersonal skills and analytical thoughts Tool & Platform Expertise Healthcare coding system ICD9 and 10, HCPCS, CPT, NDC etc. Use programming languages and tools such as SAS, R, R-Shiny, SQL, Python, Power BI Familiarity with RWE platforms lik...

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may indepen...

J OB DESCRIPTION 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 f...

1. Advanced skills in statistical and biostatistical analysis 2. Ability to communicate effectively in the English language in person, by phone and in writing 3. Designs, plans, and execute biostatistical components of clinical studies. 4. Uses statistical methodology to conduct studies and prepares statistical components of protocols. 5. Responsible for the statistical components of reports. 6. Develops statistical analysis plans and reporting specifications for clinical studies. 7. Reviews reports and underpins the results with statistical expertise. 8. Prepares and annotates shell data displays 9. Analyzes and interprets results from clinical studies using sound statistical methodology. 1...

JOB Description: Testing Engineer About Us: Inductive Quotient was founded by statisticians and technology industry experts with over 20 years of experience Inductive quotient aims to transform businesses and processes with its advanced digitization capabilities. With advanced AI and Machine Learning techniques we are helping Life Sciences industry to create a better healthcare system, and our Data Science capabilities helps organizations to create breakthrough solutions to transform businesses and drive sales growth. Website: www.inductivequotient.com We are seeking a skilled EDC Tester to validate the functionality, usability, compliance, and performance of our clinical EDC platform. You w...

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all wri...

Role & responsibilities: Collaborating closely with clients to deliver technical consulting services and configure the elluminate platform. Guiding and supporting the team of data engineers on various technical service delivery activities. Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate Mapper, and Qlik. Providing technical guidance, training, and support to team members and users on processes, technology, and products. Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. Possessing in-depth knowledge of at least one ...

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned ...

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team ...

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, 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. Collaborating with Senior/Princ...

JD FOR R Programmer Title- Statistical Programmer/Sr. Statistical Programmer -R Programming We are seeking an experienced R Programmer to support Application development and statistical programming activities . The ideal candidate will have strong R programming skills with a solid understanding of clinical trial data, regulatory standards (e.g., CDISC, SDTM, ADaM), and open source libraries. Key Responsibilities: Develop and validate R programs to support CDISC dataset and statistical graph Create Markdown and Shiny appy for generating statistical tables and listings. Automate and streamline data wrangling, transformation, and visualization of clinical datasets using R and associated package...

Minimum experience: 8 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 we’d love to connect!

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS, SDTM dataset & specification generation. - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all wri...

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all wri...

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all wri...