272 Cdisc Jobs - Page 6

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!

Main responsibilities: The Senior Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Global Hub biostatistics and programming personnel to implement (Develop and/or QC) statistical analysis plans(SAP), programming specifications for analysis datasets and provide QCd data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable) .The Senior Biostatistician will ensure SOPs a...

Grade: L2-2 About the job As Principal Data Standards Analyst within our Clinical Information Governance, As a member of a CIG (Clinical Information Governance) team, the Principal Data Standards Analyst acts as a metadata expert as he/she provides in-depth knowledge and guidance on clinical data standards (CDISC) and best practices for metadata management across global and study-specific levels. Understand the CDISC models (CDASH, SDTM, External Data, Controlled Terminology) and all regulatory requirements regarding Data Standards. Actively leads Therapeutic Area Working Groups. The Principal Data Standards Analyst will bridge the gaps between global metadata strategy and its adoption withi...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Role Overview: As a Statistical Programming Associate Director, you will play a strategic leadership role in ensuring the quality, timeliness, and efficiency of programming deliverables across clinical or technical projects. Your strong programming expertise, deep understanding of clinical development, and ability to lead both strategic initiatives and operational execution will be crucial in contributing to cross-functional teams and driving continuous improvement across the function. Key Responsibilities: - Lead and manage the end-to-end delivery of statistical programming for clinical trials, drug development projects, or technical initiatives. - Translate clinical protocols and developme...

Role Overview: As a Statistical Programmer at Statistics & Data Corporation (SDC), 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. Key Responsibilities: - Overseeing statistical programming activities for medium to l...

Skills & Qualifications Exp - 4-6 years in Real world data analysis Qualification - Master's/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 li...

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 you'll work on a variety of projects, while collaborating with our cross-functional team of experts. You'll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. You'll 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...

- Sound knowledge and experience in working with statistical compute and data science platforms - Proven experience in Architectural Designing, implementing and governing large programs. - Solid understanding of clinical trial processes and leveraging quantitative sciences and toolsets in regulatory and exploratory pathways -Ability to assess landscape with knowledge of industry trends in clinical data flow, CDISC standards, open-source technologies, evolving analysis toolsets and cloud compute to drive sustainable roadmap of technology in Clinical enablement for Study design through data submission. About the Role Key Responsibilities: Oversee architectural activities for a specific busines...

As a Data Standards Specialist at ICON plc, you will be responsible for creating and maintaining content in the Data Standards Catalog. You will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your role will involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Additionally, you will actively participate in governance team meetings and provide input on assigned standards. You will work closely with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy and ensure compl...

In your role as a Senior Clinical Data Manager I at Allucent, you will be responsible for leading data management activities within the Allucent Data Management department. Your tasks will include: - Serving as the primary contact for data management with relevant internal and external parties. - Planning and projecting required resources, managing tasks, timelines, risks, and quality. - Monitoring tasks, budgets, forecasts, and managing changes in scope, budget, and revenue recognition. - Developing, reviewing, and maintaining project-specific data management documents throughout the project lifecycle. - Leading and coordinating the development of clinical study database set-up and eCRF des...

We are looking for an experienced and innovative Software Engineer to lead the development of our web and mobile applications tailored for the automobile service industry. The ideal candidate will have a strong background in full-stack development, mobile app frameworks, and integration with automotive-related technologies (booking systems, customer dashboards, IoT integrations, payment gateways, etc.). Key Responsibilities Design, develop, and deploy scalable mobile and web applications for automobile service operations. Build customer-facing apps (service booking, vehicle tracking, payments, feedback) and internal tools (service management, inventory, analytics dashboards). Collaborate wit...

Your Role We are seeking an experienced and collaborative Senior Statistician I to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory compliance of statistical deliverables. The Senior Statistician will also oversee quality control processes and contribute to the development of statistical analysis plans and datasets. In this role, you will: Provide statistical leadership and support for clinical trials, ensuring high-quality deliverables. Participate in cross-functional stu...

As a Statistical Programmer, your role involves performing, planning, coordinating, and implementing various tasks for complex studies. This includes programming, testing, and documenting statistical programs for creating statistical tables, figures, and listings. Additionally, you will be responsible for programming analysis datasets and transfer files for both internal and external clients. Ensuring programming quality control checks for source data and reporting data issues periodically is also a key part of your responsibilities. Key Responsibilities: - Interpret project level requirements and develop programming specifications for complex studies - Provide advanced technical expertise t...

Role Overview: You are being offered the opportunity to join as an Associate Director, PKPD / Pharmacometrics / NONMEM / SAS Programmer in the Clinical Pharmacology and Quantitative Pharmacology Data Programming team. Your main responsibility will be to prepare, program, validate, and diagnose data to support Pharmacometrics and Clinical Pharmacology analyses. Your influence will be vital in shaping crucial decision-making processes throughout all stages of drug development and regulatory interactions. Key Responsibilities: - Expertly clean, manipulate, transform, and integrate data at both the study and compound level to ensure accurate analysis. - Utilize advanced data integration techniqu...

- 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...

Company: TCS Role: Healthcare & Life Sciences Other Industry: Pharmaceutical & Life Sciences Department: Healthcare & Life Sciences Employment Type: Full-time, Permanent Role Category: Healthcare & Life Sciences Other Job Location: Mumbai, Pune, Bangalore, Delhi-NCR Experience Range: 512 years Position Overview TCS is seeking experienced Statistical Programmers with expertise in CDISC standards to support programming activities across multiple therapeutic areas. The role involves overseeing statistical programming deliverables, ensuring compliance with quality processes, and managing project timelines. Key Responsibilities Lead statistical programming activities for one or more compounds, in...

We are looking for a highly skilled Clinical Data Modeling Specialist with deep expertise in the Unified Study Data Model (USDM) to support the design, development, and governance of clinical and real-world data (RWD) models . The ideal candidate will have a strong background in data information modeling , healthcare data standards , and semantic interoperability , working cross-functionally to ensure scalable and compliant data solutions. Key Responsibilities: Design and develop data information models aligned with USDM for clinical trials and real-world data (RWD) . Collaborate with cross-functional teams to define and document LinkML schemas and metadata standards . Perform data curation ...

**Greetings from You & I Consulting!** We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming, this role is your next step forward! Senior Lead Statistical Programmer!!! We are hiring for: Senior Lead Statistical Programmer up to 22LPA ctc **To Apply Call on Puja- 8167854231 /Or Whatsapp on the same Number with your CV** Experience Level: 4 to 18 years Location-Mumbai , Kochi, Bangalore and PAN India Job Description : We are seeking an experienced and driven Senior Lead Statistical Programmer with 1015 years of experience in clinical trial prog...

TCS is hiring for Statistical Programmer!!! Job Location Mumbai/Pune/Bangalore/Delhi - NCR Experience Range – 5 to 12 Years Skillset Required – SDTM, ADAM, TFL Interested candidates are requested share updated CV with below details on the mail id – Babeeta.shahi@tcs.com 1. Experience in the statistical programming activities for one or more compounds/indications or a therapeutic area. 2. Manages a team of statistical programmers and the resource planning for their assigned projects. 3. Ensures timely deliverables, that all quality processes are followed and consistency within the projects. 4. Develops and oversees the development of SAS programs for the creation of ADaM data sets following C...

As a Project Manager in Clinical Data Management at SyMetric, your role involves handling customer projects independently with minimal supervision. Your responsibilities include: - Managing projects related to Clinical Data Management, including systems and services for IWRS/EDC/CTMS - Customer management for assigned projects - Monitoring project timelines and taking necessary actions to ensure projects stay on track - Ensuring all project deliverables are met for customer satisfaction - Serving as the primary point of contact from SyMetric Additionally, you will provide clinical data management support to the Clinical Operation Team, Sponsor, Customer, and Clinical Data Management Team. Yo...

• Ensures that the Statistical Programming department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures(SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Statistical Programming department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and mai...

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 ...

- 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...