Medical Writing, to drive efficiency and accountability. IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting. We have one of the largest Biostatistics departments within the industry of around … needs analysis for complex project or client requirements. Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. As well as … and coordinating tasks within a programming team In-depth knowledge of applicable clinical research regulatory requirements, i.e. GoodClinicalPractice (GCP) and International Conference on Harmonization (ICH) guidelines Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and More ❯
Medical Writing, to drive efficiency and accountability. IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting. We have one of the largest Biostatistics departments within the industry of around … needs analysis for complex project or client requirements. Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. You will estimate … and coordinating tasks within a programming team In-depth knowledge of applicable clinical research regulatory requirements, i.e. GoodClinicalPractice (GCP) and International Conference on Harmonization (ICH) guidelines Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and More ❯
Reading, Oxfordshire, United Kingdom Hybrid / WFH Options
IQVIA Argentina
IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home … Program quality control checks for source data and reporting data issues Interpret project level requirements and develop programming specifications Write programming code following established Good Programming Practices Program ADaM datasets Program to create statistical analysis tables, listings, and figures Validate datasets and all statistical outputs per prescribed gate checks … Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines Use and promote the use of established standards, SOPs, and standard methodologies Export data and clinical study report materials Provide training and mentoring to team members and department staff You More ❯
IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home … Program quality control checks for source data and reporting data issues Interpret project level requirements and develop programming specifications Write programming code following established Good Programming Practices Program ADaM datasets Program to create statistical analysis tables, listings, and figures Validate datasets and all statistical outputs per prescribed gate checks … Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines Use and promote the use of established standards, SOPs, and standard methodologies Export data and clinical study report materials Provide training and mentoring to team members and department staff You More ❯
work permit required: Yes Job Views: 11 Posted: 28.04.2025 Expiry Date: 12.06.2025 Job Description: IQVIA is seeking statistical programmers skilled in SAS to develop clinical study report materials for regulatory submissions. The role involves full-spectrum statistical programming in our DS3 environment, primarily home-based. Responsibilities: Import data from … various sources Perform quality control checks on source and reporting data Interpret project requirements and develop programming specifications Write programming code adhering to Good Programming Practices Program ADaM datasets Create statistical analysis tables, listings, and figures Validate datasets and statistical outputs against gate checks Communicate with statisticians and clinical … Use and promote established standards, SOPs, and methodologies Export data and report materials Provide training and mentorship to team members Join us to advance clinical trial statistical analysis with cutting-edge technology across global projects. Thrive in a collaborative, fast-paced environment that fosters professional growth and mentorship. The More ❯
South San Francisco, California, United States Hybrid / WFH Options
Amgen
drug targets. This team implements software platforms that enable the capture, analysis, storage, and report of in vitro assays and in vivo/pre-clinical studies, as well as those that manage compound inventories/biological sample banks. You will play a pivotal role in shaping the software ecosystem … vivarium. Regulatory knowledge: Experience handling GxP data and system validation. Knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP). Scientific Software Expertise : Experience using or supporting platforms from scientific software providers such as Genedata, StudyLog, Revvity, Proscia, Thermo, Benchling, IDBS, Biovia, etc. AI More ❯
off through to study close. Collaborate with customers to exceed their expectations of project outcomes. Create both customer configuration specifications from customer protocol and clinical case record forms. Ensure the quality of all customer-facing deliverables. Manage all project documentation according to defined processes. Identify risk areas and determine … succinctly. What you need to succeed Industry Experience A demonstrable track record of project management achievements in eCOA/ePRO or EDC industries. Extensive clinical trial experience for either medical device or pharmaceuticals. Team and Project Management Confidence working within a project management position in a client-facing role … trial process and an understanding of application design and development processes. Experience working within regulated environments, for example GDPR (General Data Protection Regulation), GCP & HIPAA. Nice to have PMP Certification Proven experience of delivering eClinical technology for clinical research. Experience in process improvement. Why uMotif? Unlimited paid holiday More ❯
off through to study close. Collaborate with customers to exceed their expectations of project outcomes. Create both customer configuration specifications from customer protocol and clinical case record forms. Ensure the quality of all customer-facing deliverables. Manage all project documentation according to defined processes. Identify risk areas and determine … succinctly. What you need to succeed Industry Experience A demonstrable track record of project management achievements in eCOA/ePRO or EDC industries. Extensive clinical trial experience for either medical devices or pharmaceuticals. Team and Project Management Confidence working within a project management position in a client-facing role … trial process and an understanding of application design and development processes. Experience working within regulated environments, for example, GDPR (General Data Protection Regulation), GCP & HIPAA. Nice to have PMP Certification Proven experience of delivering eClinical technology for clinical research. Experience in process improvement. Why uMotif? Unlimited paid holiday More ❯
off through to study close. Collaborate with customers to exceed their expectations of project outcomes. Create both customer configuration specifications from customer protocol and clinical case record forms. Ensure the quality of all customer-facing deliverables. Manage all project documentation according to defined processes. Identify risk areas and determine … succinctly. What you need to succeed Industry Experience A demonstrable track record of project management achievements in eCOA/ePRO or EDC industries. Extensive clinical trial experience for either medical devices or pharmaceuticals. Team and Project Management Confidence working within a project management position in a client-facing role … trial process and an understanding of application design and development processes. Experience working within regulated environments, for example, GDPR (General Data Protection Regulation), GCP & HIPAA. Nice to have PMP Certification Proven experience of delivering eClinical technology for clinical research. Experience in process improvement. Why uMotif? Unlimited paid holiday More ❯
Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelor's degree in a relevant field … based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive More ❯
Oxfordshire, Oxford, South East Hybrid / WFH Options
Computer Futures
Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelor's degree in a relevant field … based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive More ❯
Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelor's degree in a relevant field … based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive More ❯
Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelor's degree in a relevant field … based data exchange , data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive More ❯
permit required: Yes Job Reference: a630f467b321 Job Views: 8 Posted: 26.04.2025 Expiry Date: 10.06.2025 Job Description: IQVIA is seeking experienced statistical programmers to develop clinical study report materials using SAS programming language for regulatory submissions. Responsibilities include data import, quality control, programming SDTM and ADaM datasets, creating analysis tables … validating outputs, and collaborating with statisticians and clinical teams. The role offers the opportunity to work on global projects in a fast-paced, collaborative environment with development and mentoring opportunities. Qualifications: Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science At least 5 years of … with expertise in ADaM/SDTM/TLFs Key skills include SAS programming in healthcare industries, knowledge of statistics, attention to detail, understanding of GCP and ICH guidelines, leadership potential, and strong communication skills. This role is remote and does not qualify for UK visa sponsorship. IQVIA is a global More ❯
San Diego, California, United States Hybrid / WFH Options
Avidity Biosciences
. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is … cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit and engage with us on LinkedIn and X . The Opportunity We are seeking a Drug Product Process … CMOs and/or within CMOs for scale-up of new or existing drug products. Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures. What We Seek BS in pharmaceutical sciences/engineering with at least 3 years relevant and hands on experience More ❯