397 Sdtm Jobs - Page 4

ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all the deliverables Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells Setup the folder structure for the assigned study as per the SOP Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects Provide the study status to the Project Manager/Client periodically Identify, communicate, and manage study...

ROLES and RESPONSIBILITIES: Perform statistical programming review of case report forms (CRFs), annotated CRFs, database structures, statistical analysis plan (SAP) project documentation such as Statistical Analysis Plan (SAP), mock shells, programming specifications and annotated CRFs Provide the statistical programming support for assigned studies, in both production and QC of analysis dataset specifications, analysis datasets, statistical analysis tables, data listings, figures, and statistical appendices Provide the status of assigned tasks to Study Lead Programmer and Project Manager Identify, communicate, and manage study-based risks and issues Maintain supporting documentation for stu...

Job Id 284489 Hyderabad, Andra Pradesh, India Job Type Full-time Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s 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's 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, intel...

Job Id 291278 Hyderabad, Andra Pradesh, India Job Type Full-time Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s 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's 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, intel...

Position Summary The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels an...

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...

We’re Hiring–ROLE: Lead Data Science Programmer ● Location: Candidates based in Bangalore, Chennai, or Trivandrum are required to work onsite. Candidates outside these locations may opt for remote work. ● Illuminate, Spotfire and Power BI (Visualization) experience, 1st priority Python Coding_Python libraries (Pandas and NumPy) ● SDTM added advantage ● Go for Immediate Joiners, 60 days notice acceptable (Special scenario based on interview) The ideal candidate will have ● over 7 years of experience working within Data Warehouse platforms(Must) in a regulated industry, ● specifically within a clinical trial environment (IDAR). This role demands a deep understanding of ● data visualization too...

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs...

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. As a Principal Statistical Programmer you will be a key member of the Development Operations, Statistical Programming Team. You will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shel...

Job Title: Senior SAS Programmer Location : Hybrid (Hyderabad/Mumbai/Pune/Bangalore) Employment Type : Full-Time Experience : 7+ Years Job Summary: We are seeking a highly skilled Senior SAS Programmer to support the statistical programming activities for clinical trials. This role involves end-to-end SAS programming for analysis and reporting, with a focus on regulatory compliance, data standards, and high-quality deliverables. The ideal candidate should have strong experience in efficacy analysis, SDTM and ADaM generation, and TLF programming. Key Responsibilities: Perform data manipulation, analysis, and reporting of clinical trial data, including both safety and efficacy datasets (ISS/IS...

Job Description Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed. Key Activities: • Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listi...

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. Job Summary The SAS Programmer will be responsible for providing SAS programming support for the Statistics and Data Management functions for all clinical trials and regulatory submissions. The candidate will work closely with Biostatisticians and Data Managers to create SAS programs...

Overview The Data Engineer II will work closely with clients and provide technical consulting services, configuration of the elluminate platform, development for specific projects that include trial configuration, quality control, process improvements, system validation, custom analytics development, clinical software implementations and integrations. platform configuration, ETL and custom analytics development. The Data Engineer II will engage in technical development and implementation of various software service delivery related activities. As a Data Engineer II, you will play a crucial role in providing high-level technical consulting services and configuring the elluminate® platform. Yo...

Key Accountabilities Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Provide leadership, project specific training, stakeholder management, external spons...

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s 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's 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 s...

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 Senior 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 As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Role & responsibilities Develop and maintain data formatter repository structure. Develop data formatter for data transfer per project specific data transfer plan (DTP). Develop data processing tools for data ingestion and data export. Develop test scripts to ensure correct functionality of the developed data management tools. Document code, procedures, tests used for data QC, clinical data integration, and data transfer operations. Develop data pipelines for integration with internal and external systems. Develop Data Transfer Plans in collaboration with the Software Engineering teams. Develop in a team environment with source code management. Performs other departmental and study-related a...

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...

. Roles and Responsibility • Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. • Program and plan the integration of databases from multiple studies or sources. • Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with i...

Bachelor's degree from reputable university preferably in science/ mathematics related fields Preferred SAS® certification Technical Skills Requirements Must have expertise of SAS® Base, and good knowledge of SAS® graph and SAS® Macros. Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. Must have excellent knowledge of CDISC standards (SDTM and ADaM) Thorough understanding of relational database components and theory. Excellent application development skills. Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. Good understanding of ICH E6, ICH E3, ICH...

Essential Function The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other functional areas as required. General areas of responsibility also include import/export programming specification development, test data creation and test data entry, i...

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!

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...

About The Job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for a...