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SDTM Automation Business Analyst

Spotline

Remote • Today

Easy Apply

Contract, Third Party

Depends on Experience

Senior Process / Business Analyst / Manager – Finance & Accounting & Automation

Tanisha Systems, Inc.

Irvine, California • 21d ago

Easy Apply

Contract, Third Party

Depends on Experience

Business Analyst

Vaco by Highspring

Columbus, Ohio • Yesterday

Easy Apply

Contract

$35

Business Analyst

MDMS Recruiting

New York, New York • Today

Easy Apply

Contract

$65 - $70

ServiceNow Business Analyst

STAND 8

Los Angeles, California • Today

Easy Apply

Contract

$55 - $65 per hour

Director of AI Engineering

Motion Recruitment Partners, LLC

Remote or Pasadena, California • Today

Easy Apply

Full-time

QA Automation Lead

BESTPEGASUS LLC

New York • Today

Easy Apply

Third Party, Contract

PKPD & PMx Data Scientist - PK Data Delivery

Eli Lilly and Company

Indianapolis, Indiana • Today

Full-time

USD 90,000.00 - 195,800.00 per year

SDET/QA Automation

Photon

Dallas, Texas • 14d ago

Easy Apply

Full-time

$60,000 - $120,000

QA Automation Architect

Qualizeal

Ashburn, Virginia • 22d ago

Easy Apply

Full-time

Depends on Experience

SDET/QA Automation Engineer

Tech Pundits

California • Today

Easy Apply

Full-time, Third Party, Contract

Senior Automation Test Lead

Elite Workforce Inc

Raleigh, North Carolina • Today

Contract, Third Party

Automation Developer

West Advanced Technologies, Inc.

Sacramento, California • Today

Easy Apply

Contract, Third Party

AI Data Engineering Intern (BS)

Eli Lilly and Company

Indianapolis, Indiana • Today

Full-time

USD 65,600.00 per year

Lead AI & Data Engineer

Dassault Systems Americas Corp.

New York, New York • Today

Full-time

USD 135,000.00 - 180,000.00 per year

Sr. Automation Architect

Sky Solutions LLC

Woodlawn, Maryland • Yesterday

Easy Apply

Contract

Depends on Experience

Sr. Automation Architect

International Software Systems, Inc

Owings Mills, Maryland • 8d ago

Easy Apply

Full-time

100 - 104

Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management (Hybrid)

Merck & Company Inc

North Wales, Pennsylvania • Today

Full-time

USD 142,400.00 - 224,100.00 per year

Business Analyst

ArnAmy, Inc.

Tallahassee, Florida • 9d ago

Easy Apply

Third Party, Contract

55 - 60

Data & Automation Manager

Airbus

Herndon, Virginia • Today

Full-time

USD 87,000.00 - 112,000.00 per year

Marketing Automation Specialist

Robert Half

Remote or Doylestown, Pennsylvania • Today

Easy Apply

Contract

USD 47.50 - 55.00 per hour

Marketing Automation Specialist

Robert Half

Atlanta, Georgia • Today

Easy Apply

Full-time

USD 110,000.00 - 115,000.00 per year

SOX Automation Engineer

ELYON International, Inc.

Washington, District of Columbia • Today

Full-time

GTM Systems Analyst

Ashby

Remote or Canada, Kentucky • Today

Full-time

USD 115,000.00 - 162,438.00 per year

Automation/SDET Test Engineer

Software Guidance & Assistance

New York, New York • Today

Contract

Senior Automation Manager

S&P Global

New York, New York • 24d ago

Full-time

USD 120,000.00 - 140,000.00 per year

PMT Engineer - Analytics and Automation

BorgWarner

Auburn Hills, Michigan • Today

Full-time

USD 100,800.00 - 141,750.00 per year

Lead Automation Technician

Jobot

Waukesha, Wisconsin • Today

Full-time

USD 25.00 - 45.00 per hour

Lead Automation Technician

Jobot

Milwaukee, Wisconsin • Today

Full-time

USD 25.00 - 45.00 per hour

Business Analyst

V2Soft

Tallahassee, Florida • 15d ago

Easy Apply

Contract, Third Party

Depends on Experience

Job Details

Skills

SDTM Automation
Business Analysis
ADaM
CDISC

Summary

Position: SDTM Automation Business Analyst

Location: Remote, PST hours

Duration: 12+ Months

Job description:

The SDTM Automation Business Analyst bridges clinical data science, statistical programming, and IT engineering. You will lead the analysis, design, and optimization of automated pipelines that transform raw clinical trial datasets into CDISC SDTM (Study Data Tabulation Model) and ADaM regulatory submission formats. You will partner with biostatisticians, statistical programmers, and software engineers to scale machine-learning or rule-based automation tools that reduce manual mapping and validation effort.

Key Responsibilities

Requirements & Process Analysis:

Partner with Clinical Data Management and Statistical Programming teams to map current-state ("As-Is") vs. future-state ("To-Be") SDTM conversion and validation workflows.
Translate complex clinical protocol requirements and CDISC standards into clear functional specifications, user stories, and acceptance criteria for automation platforms.

Automation & Solution Design:

Drive the design of automated data-mapping, translation, and conformance-checking tools (e.g., SAS, R, Python, or AI-driven pipelines).
Identify bottlenecks in clinical data standards implementation and propose scalable, low-maintenance technology solutions.

Validation & Compliance:

Author, execute, and document System Development Life Cycle (SDLC) artifacts, validation plans, and User Acceptance Testing (UAT) scripts in compliance with FDA, EMA, and GxP standards.
Ensure data integrity, traceability, and regulatory readiness for submission-ready SDTM datasets.

Stakeholder & Vendor Management:

Act as the primary liaison between clinical domain experts, IT engineering, and external technology vendors.
Lead backlog grooming, sprint planning, and release coordination in an Agile/Scrum environment.

Qualifications & Requirements

Basic Qualifications

Bachelor’s degree in Computer Science, Information Systems, Biostatistics, Bioinformatics, or a related scientific/technical field.
5+ years of experience as a Business Analyst, Data Analyst, or Technical Product Analyst within the biopharmaceutical, clinical research (CRO), or life sciences sector.

Preferred & Technical Skills

CDISC Standards: Deep, practical understanding of CDISC SDTM, ADaM, and Define-XML standards.
Technical Fluency: Familiarity with clinical programming languages (SAS, R, or Python) and clinical data management systems.
Automation & Analytics: Experience working on data pipelines, ETL processes, or AI/ML-driven clinical data transformation initiatives.
Regulatory Knowledge: Working knowledge of FDA/EMA electronic submission requirements (e.g., eCTD, Pinnacle 21 validation checks).
Methodologies: Experience with Agile/Scrum tools (Jira, Confluence) and GxP system validation protocols.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: RTX18f0cc
Position Id: 9128178
Posted 5 hours ago

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Contact the job poster

Vikas Sharma

IT Recruiter @ Spotline

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Today

Position: Business Analyst - Clinical Data & TFL Submission Package Location: Remote, PST hours Duration: 12+ Months Job descripiton: We are seeking a data-driven Business Analyst specializing in TFL (Tables, Figures, and Listings) Submission Packages to bridge the gap between clinical data operations, biostatistics, and regulatory affairs. In this role, you will define requirements, map data workflows, and ensure that all clinical trial documentation complies with global regulatory standards (F

Easy Apply

Contract, Third Party

Depends on Experience

Sr. Principal Clinical Data and Solutions Architect

Remote or Minneapolis, Minnesota

•

Today

We anticipate the application window for this opening will close on - 30 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building

Full-time

USD 166,400.00 - 249,600.00 per year

Principal Clinical Datawarehouse Programmer

Remote

•

Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Principal Clinical Datawarehouse Programmer will be responsible for the development and support of ETL (Extract, Transform, Load) data pipelines. Work with business/pr

Full-time

USD 125,000.00 - 165,000.00 per year

Clinical Data Enablement

Remote

•

15d ago

Role: Clinical Data Enablement - Senior Manager Job Location: USA (Remote) Objective / Purpose: The Clinical Data Enablement Senior Manager is responsible for operating and continuously improving end-to-end clinical data pipelines across cloud-based data lake and data warehouse environments. This role builds scalable ingestion and transformation capabilities, partners closely with internal stakeholders and external vendors, and ensures reliable, compliant delivery of clinical data products to d

Easy Apply

Full-time

Depends on Experience