627 Sdtm Jobs - Page 14

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...

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...

Description Manager 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 solver...

Job Summary: We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management. Key Responsibilities: Operational Oversight Manage timelines, resource allocation, and deliverables for clinical programming projects. Track progress against milestones and proactively address risks or delays. Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP). Team Coordination Facilitate communication between pr...

THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK .Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for ou...

Key Responsiblities Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Strong proficiency implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) Develop and review SAS programs for data analysis, tables, figures, and listings, and ensure accuracy and consistency of data output Qualifications: Bachelor’s or Master’s degree in a data science field, e.g., statistics, ma...

HybridOperations, Data ManagementFull time Bengaluru, Karnataka, India OVERVIEW Description Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team Lead SDTM programmer. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. The Lead SDTM Programmer is responsible for providing SDTM Programming input fo...

Location Bengaluru, Karnataka, India Job ID R-233362 Date posted 12/08/2025 Job Title: Associate Director Data Management Introduction to role Are you ready to lead and inspire a team in the world of Clinical Data Management? As a Clinical Data Management Team Leader, you'll oversee the delivery of high-quality data for assigned projects or indications, whether through external partners or internally run studies. You'll be at the forefront of process development and improvement, staying informed about the latest trends in CDM approaches. Your role will also involve training and coaching junior colleagues, ensuring they reach their full potential. Accountabilities In this dynamic role, you'll...

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...

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...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. 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 business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing i...

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Senior - Clinical Integration Developer EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial...

Experience Range : 2-3 Years CTC: Upto 15LPA Role 1:: Data Scientist (Clinical) We are seeking a highly skilled Data Scientist with strong expertise in clinical data standards and regulatory submission formats. The ideal candidate will have hands on experience working with OMOP and SDTM data models, capable of converting raw, heterogeneous clinical datasets into standardized formats required for regulatory submissions to agencies such as the FDA and PMDA. Key Responsibilities Convert and standardize clinical datasets originating in OMOP format into SDTM format according to CDISC regulatory submission guidelines. Data harmonization and - must have skill set for shortlist Design the ETL (Extra...

As a Data Management Specialist, you will be responsible for designing and reviewing Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. You will develop and maintain Data Management Plans (DMPs), data validation specifications, edit checks, and coding guidelines. Your role will involve overseeing data entry, data cleaning, discrepancy management, and query resolution processes to ensure data integrity. It will be your responsibility to ensure compliance with industry standards such as CDISC (CDASH, SDTM) and regulatory guidelines from FDA and ICH-GCP. You will be involved in conducting User Acceptance Testing (UAT) of EDC systems and monitoring data quality throughout the pr...

You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves develop...

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Observational research (OR) is an increasingly important component in drug development and commercialization, because in the current environment, there is increased demand for information from OR studies for regulatory and reimbursement authorities. The Center for Observational Research ...

6-8 years of experience in Clinical Data Management/Clinical Data base programming or relevant field. Location: Mumbai Pune, Bangalore, Hyderabad, Kolkata Good technical experience on EDC systems (Rave/Veeva) Ability to provide technical expertise. Proactively communicate ownership of studies. Critical thinking to identify root causes and best practices. Knowledge of create high quality EDC specification. Knowledge of both SDTM and C-DASH (Clinical Data Acquisition Standards Harmonization) Knowledgeable of study protocols and create specifications that align to key deliverables. Knowledge of creation of Edit check specification and knowledge of programming edit check Knowledge of EDC design ...

Hiring For: Multiple Leading MNCs Job Summary: We are hiring skilled and experienced SAS Clinical Programmers to join our global teams working with leading pharmaceutical companies and CROs. As a SAS programmer, you will be responsible for supporting clinical trial data analysis, CDISC implementation, and regulatory submissions across various therapeutic areas. Key Responsibilities: Develop, validate, and maintain SDTM and ADaM datasets , tables, listings, and figures (TLFs). Support clinical trial data analysis as per CDISC standards . Work closely with biostatisticians and data managers to ensure data quality and integrity. Write and validate SAS codes as per project and regulatory require...

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Senior - Clinical Integration Developer EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial...

Job Title: Principal Programmer Statistical Programming Introduction To Role Are you ready to take on a pivotal role in statistical programmingAs a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers This is your chance to integrate statistical concepts with SAS Programmi...

The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related ...