397 Sdtm Jobs - Page 6

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...

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collabo...

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. Interact with sponsors and internal stakeholders with regard to statistical programm...

Description Senior Statistical Programmer(SDTM + ADAM + TLF) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passiona...

As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing The role is part of the Submissions Center of Exellence Will need to keep informed of the latest regulatory requirements The programming of SDTM datasets, ADaM datasets, and TFLs will still be the responsibility of the trial clinical/statistical programmer Qualifications Previous experience submitting data to regulatory authorities is preferred Will take on the post-database lock activities related to making SDTM and ADaM data packages submission-ready (per latest requirements) Resizing datasets, removing empty var...

We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment wi...

Position Overview : We are seeking a skilled Statistical Programmer to join our clinical research team. The successful candidate will be responsible for programming, validating, and delivering statistical outputs for clinical trials while ensuring compliance with regulatory standards and industry best practices. Key Responsibilities : Programming & Data Management : - Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting. - Map clinical trial data to CDISC standards (SDTM and ADaM) ensuring compliance with regulatory requirements. - Create and maintain analysis datasets following CDISC implementation guidelines. - Perform data validation and quality co...

About The Job Our Team: Sanofi Global Hub 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 Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Biostatistician will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications ...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastru...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastru...

Senior Statistical Programmer I Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and m...

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 Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages inc...

About the job Our Team: Sanofi Global Hub 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 Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Biostatistician will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for p...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastru...

Job Title: Senior Clinical Data Scientist / Clinical Data Analyst Experience: 7+ Years Location: Bangalore / Chennai / Hyderabad / Noida / Gurgaon (India) Industry: Pharmaceutical / Healthcare / Life Sciences Employment Type: Full-time Job Summary: We are seeking a highly experienced and analytical Senior Clinical Data Scientist / Analyst with 7+ years of experience in clinical data analysis, pharmaceutical research, and data science methodologies . The ideal candidate will have hands-on experience working with EMR/EHR data , advanced SQL , and machine learning models to derive actionable insights that support clinical research and drug development. Key Responsibilities: Analyze and interpre...

Description Mgr, Statistical Programming Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, ...

The Statistical Programmer II position at Princeps Technologies in Hyderabad is a key role within our organization. As a data-driven company specializing in advanced analytics and technology solutions for the pharmaceutical and biotechnology sectors, we are dedicated to innovation, quality, and client success. As a Statistical Programmer II, you will be responsible for developing and validating SDTM datasets according to CDISC standards, creating ADaM datasets following current guidelines, and programming Tables, Listings, and Figures (TLFs) as per sponsor requirements. Your role will also involve generating subject narratives, producing clinical registry files, performing quality control on...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastru...

1. Design and development of CV, Steering and front axle aggregates 2. knowledge Bus and load platform 3. Casting and forging manufacturing processes knowledge, 4. DMEA, DFA, DFS, DFM. 5. Knowledge of DVP, 6 Hands on experience in CATIA. 6. Ability to resolve the problems, 7. Basic knowledge of vehicle dynamics ADAMs, MBD. 8. Knowledge of Homologation requirements.

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...