FDMA Jobs in San Diego, CA

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Python Developer - (clinical data)

Radiant System, Inc

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Remote

Contract

Seeking a Python Developer with strong experience in clinical data standards (SDTM/CDISC) and a background in the pharmaceutical industry. Role involves developing automation pipelines and AI/ML models to transform clinical trial data into SDTM-compliant datasets. Must-Haves: 8+ years in pharma/clinical domain 3+ years Python development SDTM, CDISC, ADaM, raw datasets Experience with AI/ML (NLP, classification) Tools: Pinnacle 21, Define.xml Nice-to-Have: Metadata-driven automation Knowledge of
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Posted 23 hours ago

Senior Biostatistician

System Edge (USA) L.L.C.

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Remote

Contract

Position: Senior Biostatistician Location: Remote/EST time zone Contract- Long termAt least 6-8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (
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Posted 19 hours ago

Senior Biostatistician

Georgia IT

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Remote

Contract

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu
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Posted 21 hours ago

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

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Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato
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Posted 1 day ago | Updated 1 day ago

Principal Technical Consultant - SQL Server 2025 Engineer

Nasscomm, Inc.

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Remote

Contract, Third Party

Role: Principal Technical Consultant - SQL 2016 Engineer Scope: SQL administrator to perform the following tasks in SQL 2016 to SQL 2025 upgrade initiatives: o Assessment and planning - Includes inventory, DMA scans, risk analysis o Installations/Configuration - Install SQL 2025 on Server 2022, Configure SQL to fit environment/application specifications o Compatibility Testing - Includes app testing, UAT o Migration - Move data to new servers and work with vendors/app owners for testing, Rollbac
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Posted 21 hours ago | Updated 1 hour ago

SAP Developer Lead Remote Location

Sierra Business Solution LLC

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Remote

Contract, Third Party

Job Description: >> Lead SAP development projects and provide technical guidance across modules and platforms. >> Manage and coordinate activities of an offshore SAP development team, ensuring high-quality deliverables. >> Develop, enhance, and maintain SAP applications using SAP Workflow, FioriUI5, Web Dynpro (ABAPJava), SAP Enterprise Portal, BRF+ (Business Rule Framework Plus), LSMW (Legacy System Migration Workbench). >> Perform root cause analysis and debugging of complex SAP issues across
Posted 16 hours ago | Updated 1 hour ago

clinical Python Developer (100% Remote)

AKAASA Technologies

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Remote

Contract

Required: Master's degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development Strong understanding of SDTM standards and CDISC requirements. Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms). Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures. Excellent problem-solving and collaboration skills. Experience working with clinical trial
Posted 21 hours ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

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Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis
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Posted 2 days ago

Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLC

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Remote or Rochester, Minnesota, USA

Contract

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist
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Posted 3 days ago | Updated 2 days ago

Python Developer

Hired by Matrix, Inc.

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Remote or Nutley, New Jersey, USA

Contract

At-a-Glance: Are you ready to build your career by joining a global pharmaceutical company. If so, our client is hiring a Python Developer.Position Type: Contract RemoteRequired: Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development Strong understanding of SDTM standards and CDISC requirements. Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms). Familiarit
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Posted 1 day ago | Updated moments ago

Clinical Data manager

Intone Networks Inc.

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Remote

Third Party, Contract

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T
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Posted 6 days ago | Updated 1 day ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical
Posted 4 days ago | Updated 5 hours ago

Statistical Programmer

System Edge (USA) L.L.C.

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Remote

Contract

Statistical Programmer Anywhere in US EST time zone- candidate need to work in EST time Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with inter
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Posted 19 hours ago

Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

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Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol
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Posted 17 days ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

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Remote

Third Party, Contract

Job Title: IT Project Lead V Location: Remote. Duration: 15+ Months (Extendable) Duties: This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantageUnderstanding of clinical, research, or diagnostic lab workflowsKnowledge of regulatory requirements (GxP, FDA 21 CFR
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Posted 1 day ago

Network Engineer

Pyramid Consulting, Inc.

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Remote

Contract

Immediate need for a talented Network Engineer. This is a 12+months contract opportunity with long-term potential and is located in Santa Ana CA (Remote). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-78795 Pay Range: $50 - $55/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Monitor and react quickly to issues f
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Posted 7 days ago

Senior Staff Firmware Engineer (Hybrid)

Becton Dickinson & Company

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Remote or Milpitas, California, USA

Full-time

Job Description Summary Seeking an experienced Senior Staff Firmware Engineer to lead the development and evolution of high-quality instrument control firmware for BD's flow cytometers. You will provide technical leadership and architectural guidance to ensure robust and reliable firmware solutions. As a key member of the firmware development team, you will architect, develop, debug, and document firmware that meets product requirements with high reliability and robustness. You will provide sig
Posted 60+ days ago | Updated 5 hours ago

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

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Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in
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Posted 2 days ago

Statistical Programmer

Georgia IT

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Remote

Contract

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,
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Posted 1 hour ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 25 days ago | Updated 5 hours ago