397 Sdtm Jobs - Page 3

You will be responsible for creating and maintaining CDISC compliant datasets (SDTM, ADaM) and generating Tables, Listings, and Figures (TLFs) for clinical study reports. Your role will involve performing efficacy analyses using R programming, developing standard macros for data manipulation, and participating in study handling activities if you are at a senior level. You will utilize the CRT package for data analysis and contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses. Working within a Functional Service Provider (FSP) environment, you will troubleshoot programming issues, ensure compliance with regulatory guidelines and company SOPs, and c...

Position: Data Engineer, Sr - I *** JOB DESCRIPTION *** OVERVIEW The Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems...

Experience in leading a team of statistical programmers for a compound/indication or therapeutic area Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle Good to have experience in other statistical programming languages (R). In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience etc.) Experience with regulatory filings. Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writi...

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...

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...

Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5252 Position Summary The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities. Essential functions of the job include but ar...

Role & responsibilities Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Preferred candidate profile 5+ years work experience in ADAM and R programming Experience with R Pack...

Position Summary The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities. Essential functions of the job include but are not limited to: Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

Openings for Statistical Programmer - Band - 4/5/6 Salary Up-to - 30 LPA + VAriables Any Grad / PG with - 5 yrs of exp Clinical SAS , Creation & Validation of ISS & ISE reports Development of sas macros etc Call @ WhatsApp- Shubhani -8595849767

As an Implementation Consultant reporting to the Product Owner, your key responsibilities will include creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. You will be tasked with developing wireframes and mock-ups for clinical reports, as well as communicating with Clinical Data Management & Medical Reviewers to document clinical reporting needs. It is essential that you stay up-to-date with all Saama product features and releases. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will act as a Clinical Subject Matter Expert, providing support for...

About The Role Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, conn...

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

Minimum experience: 8 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 we’d love to connect!

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...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

Summary Provide timely & professional ongoing Mgmt of Data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team. Help developing content and redefining training modules into engaging & interactive applications for Clinical Data Mapper onboarding. Leverage AI-based Clinical Pipeline technology to ensure process simplification and training delivery. Follows data privacy, data-handling procedures and guidelines. Participates in the discussion with Data Scientist/ Data Services or other stakeholders requesting for legacy data mapping effort and translate their needs into data operations. D...

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...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical developmen...

The R&D Programmer III position at Teva Pharmaceuticals in Bangalore, India offers an exciting opportunity for a Senior Clinical Programmer to support clinical projects and regulatory submissions. As part of a global team dedicated to making good health more affordable and accessible, you will play a lead role in generating and validating analysis datasets, tables, listings, and figures. Your expertise in SAS programming will be crucial in developing global data standards, including SDTM, ADaM, and Teva's database structure. Your responsibilities will include working at the project level, providing input for budget planning, delivering assignments with quality and within timelines, overseein...

Join Clario’s industry-leading Digital Physiology team as a Principal Statistical Programmer, where your expertise will drive innovation in clinical research. This is a unique opportunity to lead advanced statistical programming for cardiac safety trials, shaping the future of digital health through cutting-edge data science and global collaboration. What we offer Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What you'll be doing Statistical Programming & Data Standards Lead and coordinate all statistical programming activities for cardiac saf...

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 clinica...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As a Manager in Clinical Data & Technology within Life Sciences Consulting at EY, you will be part of our Life Sciences sector team, assisting clients in reimagining their clinical data strategies and implementing cutting-edge solutions across trial data capture, management, and analytics. You will play a strategic role in shaping next-gener...

As part of this role, you will be assisting in the development and implementation of solutions for global technical service issues related to EDC, SAS, or other proprietary software. Your responsibilities will include developing and validating Custom/Complex SDTM/SAS datasets, listings, and reports, as well as efficiently handling external data and data reconciliations. You will be responsible for configuring and implementing EDC services within assigned projects to ensure project integrity and on-time delivery of quality data. In addition, you will act as a technical liaison with project team members, clients, and Data Managers to drive the technical aspects of project delivery. You are exp...

ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions...