400 Sdtm Jobs - Page 14

Senior Biostatistician Location: Chennai, India (Hybrid/Remote options available) Department: Biostatistics About the Company A well-established, full-service CRO with over three decades of experience supporting statistical analyses and programming across all phases of drug development. The Biostatistics Division is recognized for its scientific integrity, quality deliverables, and timely execution. Role Overview The organization is seeking an experienced Senior Biostatistician to lead statistical activities in clinical trials. This individual will uphold high standards of scientific rigor and ensure regulatory compliance while working closely with teams across clinical data management, prog...

Job Description SDTM Mapping with SAS,SQL End to End SDTM Mapping activities Spec creation Validation and CRF Experience and Skills Required Minimum 3+ years in End to End SDTM Mapping activities Location- Mumbai/ Pune/ Bangalore SDTM Mapping activities Skills Required RoleSDM Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills SDTM MAPPING ACTIVITIES Other Information Job CodeGO/JC/21472/2025 Recruiter NameSangeetha Show more Show less

Strong experience in Statistical Programming(SDTM, ADAM, TLF )in clinical domain using R (must required) and SAS. Data analysis, visualization and advanced statistical modeling using R and SAS will be an added advantage. Should have experience in programming SDTM, ADAM, TLF in the clinical domain. Develop, validate, and implement statistical models using SAS and R. Analyze large datasets to identify trends, patterns, and insights. Design and generate reports and dashboards for various stakeholders. Automate data processing tasks using SAS macros and R scripts. Collaborate with cross-functional teams to understand data needs and deliver actionable insights. Ensure data quality and integrity t...

Location Bengaluru, Karnataka, India Job ID R-226586 Date posted 28/05/2025 Job Title: Senior Statistical Programmer II – Early Phase Career level: D Introduction to role: Are you ready to make a difference in the world of medicine? As a Senior Statistical Programmer II - Early Phase, you'll be at the forefront of statistical programming activities for early phase studies across various therapeutic areas. You'll ensure compliance with SOPs, maintain programming infrastructure, and produce quality deliverables. Whether leading projects or collaborating with biostatisticians and programming teams, your expertise will be crucial in developing oversight plans and ensuring adherence to regulatory...

Hi, Wishes. Pleasure connecting with you. Job Summary: We are hiring mid-level Statistical Programmers (4 - 8 years of experience) with strong hands-on expertise in SAS programming for clinical trials. The role requires experience in SDTM and ADaM dataset creation, TLF programming, and knowledge of CDISC standards. You will be working on end-to-end programming activities for Phase IIV clinical studies. Mode of Work : WFO Exp Range : 4 to 8 yrs Work Location : CHENNAI CTC Range : Best in the industry ***** Looking for SHORT JOINERs ***** Key Responsibilities: SDTM Programming: Create and validate SDTM datasets as per CDISC guidelines. Perform CRF annotation and author/review specifications . ...

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. Quality Control Specialists will maintain project level perspective, focus, and communicate effectively ...

Manager, CSAR - Global Library Manager What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. Th...

Position Summary The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. 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) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timel...

Roles and responsibilities: 1) Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in de...

Description JD: Data Manager, Clinical Data Management 10-15 years industry experience Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of the clinical data management and clinical operations process? If yes, Saama is looking out to hire you as we believe it should not take this long to get Drugs out to Market, we believe data and analytics powered by Machine Learning and Artificial Intelligence if put to proper use within Clinical Operations and Data Management organizations can bring significant time and outcome savings. We have re-imagined data-management processes and helped organizations significantly bring down the ti...

Position Summary: The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. 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) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a time...

Pharmaceutical & Life Sciences Full-Time Job ID: DGC00485 Chennai, Tamil Nadu 0-3 Yrs ₹4.5 - ₹7.5 Yearly Job description Role & responsibilities: Overseeing the collection, validation and processing of clinical trial data. Developing and implementing data management procedures for clinical trials. Supporting and facilitating the review of medical coding for validity and completeness. Ensuring compliance with applicable regulations, protocols and standard operating procedures in India. Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock. Stay updated on industry best practices, technological advancements and regulatory requirements ...

Summary The purpose of the role is to inventory all of the various data flowing into, across, and out of Novartis Statistical Compute Environments (SCE) and document data modalities, flows, storage, mappings and transformations, as a member of the SCAPE project team. The SCE is under development and will ultimately be used by the Development Advanced Quantitative Sciences (AQS) business domain. This role will collaborate with other SCAPE project workstreams and team members to ensure reliable and efficient data flows are established, documented and maintained according to project timelines and budget. Sound knowledge and experience in working with statistical compute and data science platfor...

Summary Assist in the 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. Ensure high quality data available for secondary analysis use. Support content development and upgrade to training modules into engaging and interactive applications. Follows data regulations and laws, data-handling procedures and data mapping guidelines. Supports quality deliverables within Clinical Data Operations (DO). Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical D...

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: Associate Director, Statistical Programming Introduction to role The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all fil...

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 Team Lead Statistical Programmer 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...

Description Principal Statistical Programmer 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 solve...

Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, sum...

Job Overview Provide programming support as part of the Statistical Programming (SP) team to develop and maintain programs to meet internal and external clients’ needs. Support the development of project-related solutions to a variety of statistical programming tasks. Essential Functions Program, test, and document statistical programs for use in creating statistical tables and listing summaries. Program analysis databases (derived datasets) and transfers of data for internal and external clients. Program database quality control checks. Assist in development of programming documentation including plans and specifications, as appropriate. Assist in developing, implementing and validating new...

Job Overview Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective. Essential Functions Interprets the study protocol. Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable. Create and update Edit Specification Document. Generate specifications for E...

Internal/extrernal stakeholders, project team members, vendors Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; ...

Functional consultant with SAP Configuration experience ideally in MDM (Article master), or second choice MM module (Material master) - EXPERT LEVEL Rxperience in SAP Retail (SAP vertical solution IS Retail) Person should be well versed with standard SAP Concepts of Assortment, Listing, Merchandise Category, etc. know SAP transaction MM41 (Article master) or MM01 (Material master MDM delas with lots of mass changes and some experience with LSMW, MM46, MM17, bespoke programs, or 3rd party tools like Process Runner, Innowera, etc Primary Skills Experience in MDM/ MM with IS- Retail Configration exp in MDM or MM

Key Skills: Adam, SDTM Roles and Responsibilities: Lead statistical programming activities as Trial Programmer for assigned studies or project-level activities including requirements analysis, resource estimation, planning and tracking, development of programs and validation of deliverables Develop and review programming dataset specifications Coordinate activities of all programmers assigned to the same study or project. Conduct kickoff meeting to provide an overview of the study or project, discuss deliverables, roles and responsibilities, timelines, and conventions Remove barriers to facilitate quality, timely and efficient completion of deliverables. Ensure that programmers have all requ...

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM...