271 Cdisc Jobs - Page 7

- 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...

Designation: Clinical Data Manager Full Time Opportunity Location: Full Time Job Description: - 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 ...

Shift: 2pm - 11pm IST (Remote) Role & responsibilities Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS. Program reports and listings as requested by project team members for ongoing studies. Develop transfer specifications with vendors for external data sources. Perform consistency checks on data transferred between client and external parties to ensure completeness and accuracy of data contained transfers. Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format Perform Quality Control (QC) on programming work performed by fellow Database Programmers. Create and validate glob...

Dear Candidate, Below are the Job Details for Clinical SAS Programmer role at CBCC Global Research LLP. Candidate should have the exposure of SDTM, ADAM and TLF. Job Location : Ahmedabad At Office Position : 2 Experience: 2-5 years in CRO preferred / Pharma industry Qualification : M. Sc. Statistics/Any Science Graduate Mandatory experience in Clinical trials Responsibilities: Ensure consistently high quality outputs for reporting and submission- 1.1. Build SAS datasets from clinical database. 1.2. Develop SAS macros, templates and utilities for data cleaning and reporting. 1.3. Utilize SDTM guidelines to build datasets. 1.4. Communicate with an internal team to create deliverables for pharm...

In this vital role, you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate Real-World Evidence (RWE) from real-world healthcare data assets. The ideal candidate should possess a bachelor's degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and either SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed...

As a Statistical Programmer II at Advanced Clinical, you will play a crucial role in providing programming support for clinical trials. Your responsibilities will include exceeding the expectations and responsibilities of a Statistical Programmer I, understanding and implementing CDISC and other regulatory standards, and following internal SAS programming conventions. You may also serve as a programming lead, prepare programming specifications for SDTM, ADaM, and other derived datasets, and work with cross-functional team members to ensure accurate and high-quality statistical outputs. In this role, you will apply your knowledge of SAS programming to program and develop statistical outputs a...

We’re hiring Statistical Programmers for Mumbai, Pune & Bangalore | Salary: 11–20 LPA | General Shift | Min. 2+ yrs SAS programming + International BPO exp. required Graduation is mandatory Required Candidate profile | Lead global clinical programming & regulatory projects

You will be responsible for creating and maintaining CDISC compliant datasets (SDTM, ADaM) and generating Tables, Listings, and Figures (TLFs) for clinical study reports. Your role will involve performing efficacy analyses using R programming, developing standard macros for data manipulation, and participating in study handling activities if you are at a senior level. You will utilize the CRT package for data analysis and contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses. Working within a Functional Service Provider (FSP) environment, you will troubleshoot programming issues, ensure compliance with regulatory guidelines and company SOPs, and c...

Position: Data Engineer, Sr - I *** JOB DESCRIPTION *** OVERVIEW The Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems...

Role & responsibilities Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Preferred candidate profile 5+ years work experience in ADAM and R programming Experience with R Pack...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

Openings for Statistical Programmer - Band - 4/5/6 Salary Up-to - 30 LPA + VAriables Any Grad / PG with - 5 yrs of exp Clinical SAS , Creation & Validation of ISS & ISE reports Development of sas macros etc Call @ WhatsApp- Shubhani -8595849767

Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate...

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

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!

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. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical developmen...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. 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 busines...

Biostatistician I Job Description: We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards. Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment. Key Responsibilities: Conduct statistical analyses as outlined in statistical analys...

Job Description Job Description: We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare s...

Purpose The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management). Key Responsibilities Supporting with CDISC implementation of studies with Real world data QC of SDTM/ADaM datasets as required Review the aCRF, Specs, relevant documentation like SDRG/ADRG, Define.xml as relevant Expertise working across different disease areas like Oncology, Vaccines, Respiratory etc Guide Real World Programmers on NIS with CDISC expectations Technical: Perform review of clinical trial...

About The Role : We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare statistical secti...

Biostatistician cum Statistical Programmer Job Description Performs biostatistical and SAS programming activities for given clinical trials involving Novel, Biosimilar and PMS studies. As a Biostatistician cum Statistical Programmer youll work on a variety of projects, while collaborating with our cross-functional team of experts. Youll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. Youll also contribute to research design and analytical strategies, provide input into protocols, Statistical Methodology and develop and review statistical analysis plans. As a Statistical Programmer, you will leverage your SAS programming skills to support Phase I-IV cl...

- 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...

Minimum experience: 10 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 wed love to connect!