619 Sdtm Jobs - Page 5

Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development. Sponsor-dedicated: 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...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The role Lilly is reimagining how clinical data is designed, transformed, and delivered—from our digital trial foundation to modern statistical comput...

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 including tables,...

Location - Chennai ( Client location) Budget - 22L Experience- 8+yrs SO - 54925613 Open Position - 5 SAS Developer - 7+ years of experience as a SAS (Statistical Analysis Software) Programming Hands-on experience with BASE SAS, SAS/MACRO, SAS/STAT; Knowledge on CDISC Standards (must require SDTM and ADaM) Analysis & Reporting end to end process (must require TFLs generations as per sponsor standards) Expert in Relational Database systems (Oracle preferred) Advanced knowledge of software development lifecycle methodologies Strong understanding of importance of coding standards and programming style. Advanced ability to write software code (full stack development). Responsibilities Designs, mo...

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years 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 pat...

Company Description MEDTEK AI is a data science-driven company focused on supporting faster drug development and healthcare solutions. Our team consists of senior statisticians, data scientists, statistical modeling and programming experts, data visualization specialists, cloud data engineers, data lake strategists, and regulatory submission and drug safety consultants. We provide comprehensive support to pharmaceutical and biotech companies across North America, Japan, and the EU. Role Description Hands on programming role, supporting deliverables in the study/project/portfolio/standards team, of medium or high complex statistical programming deliverables Strong SAS data manipulation, analy...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The role Lilly is reimagining how clinical data is designed, transformed, and delivered—from our digital trial foundation to modern statistical comput...

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 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 ...

Must have skills: Total 8-15 years of experience in Statistical programming domain Strong knowledge on SDTM, ADAM, TFL development and validation Prior experience working on global library team/Standards team would be good to have Required qualifications: Must have very good understanding of CRF build, SDTM transformation, ADaM datasets and TFLs Must have experience in using MDR driven approach especially for CRF build and SDTM transformation Must have good understanding of CDISC CDASH and SDTM standards. It would be a plus if the candidate has used any MDR products available in market. It would be a plus if the candidate has been part of MDR migration activities from legacy to new MDR It wo...

The Clinical Database Programmer is primarily responsible for LSH Setup and Data Loading activities (both Inbound and Outbound) with External Data providers Also provide support to manage the load, Transfer and conform Clinical Trial Data to Novartis Internal standards and the provision of Clinical Data extracts to Clinical Data Consumers of study-level or project level deliverables under minimal guidance About The Role Major accountabilities Contribute to LSH and Data Loading activities as Clinical Database Programmer for phase I to IV clinical studies in Novartis Global Drug Development Participate in the review of Data Transfer specification documents and provide comments if required Resp...

Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support These tasks are to be performed independently or team based with guidance and supervision About The Role Produce and track reports for various line functions within Global Drug Development, used for ongoing monitoring of clinical data Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders Facilitate interaction with en...

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 Data Warehouse...

Project role: Senior Clinical data standards specialist Work experiences: 8-10+ years. Education: Bachelor's / Master's Work location: PAN India Mode of work: Homebased Required skills: 8+ years of experience in Statistical programming domain especially clinical operations (In the area of Data management, Database programming, Data Standards, Statistical programming) Must have skills: Total 8-15 years of experience in Statistical programming domain Strong knowledge on SDTM, ADAM, TFL development and validation Prior experience working on global library team/Standards team would be good to have Required qualifications: Must have very good understanding of CRF build, SDTM transformation, ADaM ...

Role: Biostats SME Experience: 7 Plus Years Location: Noida Job Description: We are looking for an experienced & inspiring pharma leader with hands-on expertise in Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management ( EDC, non-CRF), TFLs, SDR, USDM with in-depth insights in needs, challenges and innovative trends in these domains at a global level. Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language and cross-pharma senior management network are fundamental to this role. Department description The Clinical -Standards and Digital Data Flow Leader is part of the strategic group of TCS Life Science...

Role: Biostats SME Experience: 7 Plus Years Location: Noida Job Description: We are looking for an experienced & inspiring pharma leader with hands-on expertise in Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management ( EDC, non-CRF), TFLs, SDR, USDM with in-depth insights in needs, challenges and innovative trends in these domains at a global level. Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language and cross-pharma senior management network are fundamental to this role. Department description The Clinical -Standards and Digital Data Flow Leader is part of the strategic group of TCS Life Science...

Location: Bangalore/ Mumbai /Remote (WFH) Experience: 5+ years Job Responsibilities: Strong oral and written communication skills Experience in handling complex efficacy domains and TFLs Act as subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects. Solve critical technical problems. Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, datasets, and TLFs. Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible. Provide support to mentor and train junior team members. Ensure ...

Implementation Consultant - JD Reports to: Product Owner Job Description ➢ Key Responsibilities ➢ Responsible for creating URS and functional requirement specs in Clinical Reporting and Analytics ➢ Create wire-frames and mock-ups for Clinical reports ➢ Responsible for communicating with Clinical Data Management & Medical Reviewers and document the clinical reporting needs. ➢ Should be up-to-date with all the Saama product features and releases. ➢ Should analyze and understand current business processes, events and flows in Clinical Trial Development ➢ Should be responsible for Clinical Project Support and acts as a Clinical Subject Matter Expert ➢ Responsible for authoring and documenting bu...

Implementation Consultant - JD Reports to: Product Owner Job Description ➢ Key Responsibilities ➢ Responsible for creating URS and functional requirement specs in Clinical Reporting and Analytics ➢ Create wire-frames and mock-ups for Clinical reports ➢ Responsible for communicating with Clinical Data Management & Medical Reviewers and document the clinical reporting needs. ➢ Should be up-to-date with all the Saama product features and releases. ➢ Should analyze and understand current business processes, events and flows in Clinical Trial Development ➢ Should be responsible for Clinical Project Support and acts as a Clinical Subject Matter Expert ➢ Responsible for authoring and documenting bu...

Job Description: As an EDC IT Platform Engineer at AstraZeneca, you will play a vital role in managing, improving, and maintaining the EDC product, Medidata's Rave. Your responsibilities will include facilitating key discussions with partners, participating in the validation lifecycle, conducting risk assessments, supporting code review and solutioning, creating validation test cases, resolving incidents and service requests, maintaining Rave URL(s) and its integrations, and adhering to AZ core ITIL guidelines. Key Responsibilities: - Facilitate key discussions with partners and provide SME technical support on system improvements and testing - Participate in the validation lifecycle for upg...

Description Implementation Consultant - JD Reports to: Product Owner Job Description Key Responsibilities Responsible for creating URS and functional requirement specs in Clinical Reporting and Analytics Create wire-frames and mock-ups for Clinical reports Responsible for communicating with Clinical Data Management & Medical Reviewers and document the clinical reporting needs. Should be up-to-date with all the Saama product features and releases. Should analyze and understand current business processes, events and flows in Clinical Trial Development Should be responsible for Clinical Project Support and acts as a Clinical Subject Matter Expert Responsible for authoring and documenting busine...

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...

. About the job Our Hubs are a crucial part of how we innovate, improving performance across Sanofi departments and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Principal Statistical Programmer within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than...

The Principal Data Standards Analyst (Laboratory Expert) plays a crucial role in ensuring the accurate standardization, integration, and management of laboratory data across clinical studies. This role supports Clinical Information Governance (CIG), Trial Operations (TO) , Data integration, Translational Medicine, Sample Management, and external vendors, ensuring compliance with CDISC standards (SDTM, CDASH, Controlled Terminology) and regulatory requirements. The Principal Data Standards Analyst (Laboratory Expert) also provides specialized oversight on laboratory data handling, collaborating with internal teams and external central laboratories to mitigate risks related to biomarker, genom...

Manager, CSAR - Global Library 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 Companys 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. The positio...

What you will do The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgens Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, ...