627 Sdtm Jobs - Page 16

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...

Location: Bangalore/ Mumbai /Hybrid/WFH Experience: 3 to 6 years Job Responsibilities: Strong oral and written communication skills Study Lead Experience and exposure on efficacy domains and TFLs is a plus Participates in the creation or validation of Case Report Forms (CRFs), CRF annotations, SDTM/ADAM specifications, datasets, Define, and TLFs. Proficiency in SAS and CDISC for programming. Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements. Experience in specialized therapeutic areas (TAs) such as oncology, immunology, and neurology would be a plus. Core Strength: The...

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects. This role supports the generation of real-world evidence (RWE) by programming and analyzing large-scale observational datasets. The ideal candidate will have strong SAS programming skills, familiarity with R, and experience working with healthcare claims, electronic health records (EHR), or registry data. Key Accountabi...

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 ...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Job Title: Statistical Programmer II (SDTM) Location : Chennai/ Bangalore/ Trivandrum What You Will Be Doing Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc. Review and provide input into all trial set-up documentation Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data trans...

The ideal candidate for the Senior Statistical Programming position should have a minimum of 3-8 years of experience. You should possess a strong understanding of SAS Base/Macros/GTL and have hands-on experience in SDTM/ADAM/TLFs creation following CDISC standards. Your expertise should lie in both Base and Advance SAS programming. You will be responsible for developing complex SAS macros that can be applied across Therapeutic Areas in various studies. Additionally, your role will involve reviewing the SAS programs that have been developed. Proficiency in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components is crucial for this position. As a Senior Statistical Programm...

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 ...

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent You will lead and coordinate clinical programming activities and ma...

Job Title: Statistical Programmer II Experience: 4+ Years Location: Hyderabad (Onsite) Employment Type: Full-Time About Princeps Technologies: Princeps Technologies is a data-driven organization delivering advanced analytics and technology solutions to the pharmaceutical and biotechnology industries. We are committed to innovation, quality, and client success. Role Overview: We are seeking a skilled Statistical Programmer II to join our team onsite in Hyderabad. The ideal candidate will have hands-on experience with SDTM and ADaM programming, TLF generation, and regulatory submission support within the clinical trial space. Key Responsibilities: Develop and validate SDTM datasets based on CD...

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 ...

Job 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...

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept...

Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5838 Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (L...

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...

Position Overview We are seeking an experienced SAS Programmer - Pharmaceutical to join our clinical programming team. The successful candidate will be responsible for developing, testing, and maintaining SAS programs for clinical trial data processing, CDISC dataset creation, and regulatory submission deliverables in compliance with pharmaceutical industry standards. Key ResponsibilitiesSAS Programming & Development Develop and maintain complex SAS programs for clinical trial data processing and transformation Create SDTM (Study Data Tabulation Model) datasets from raw clinical data Build ADaM (Analysis Data Model) datasets for statistical analysis Generate tables, listings, and figures (TL...

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...

Senior Clinical Data Manager - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5838 Position Summary The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the ...

Position Summary The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a ti...

Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a t...

Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a t...

3- 8 years of experience for Sr Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Expertise in Base and Advance SAS programming. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Location : - Bengaluru,Mumbai,Pune,Hyderabad Contact Person : - Sangeetha Tamil

Position Summary: The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a t...

Job title: Principal Data Standards Analyst Location: IN / Hyderabad Grade: L2-2 Hiring Manager: Manuel Anido About The Job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? 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 practi...

Job title: Principal Data Standards Analyst Location: IN / Hyderabad Grade: L2-2 Hiring Manager: Manuel Anido About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? 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 practi...

COMPANY BACKGROUND Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis). We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to ...