Skip to main content

Senior Statisticien RWE

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join a Statistics team overseeing Real-World Evidence (RWE), non-interventional, and Secondary Use of Data (SUD) studies. You will provide statistical leadership, review study protocols and analysis plans, supervise external service providers, ensure the quality and timely delivery of statistical outputs, and work closely with cross-functional teams to support evidence generation and regulatory reporting

Key Responsibilities :

- Review study synopses and protocols, including sample size calculations, study design, endpoints, and statistical methodologies.

- Oversee statistical deliverables from external service providers, including Statistical Analysis Plans (SAPs), TFLs, and interim analyses.

- Monitor study statistical milestones and track operational progress through vendor dashboards.

- Ensure the timely delivery of statistical outputs and analysis datasets in compliance with Ipsen quality standards.

- Perform quality control of statistical analyses, including SAS programming and programming validation activities.

- Review clinical study reports (CSRs) and all external communications related to study results and analyses.

Job Skills

View the job post & apply

Clinical Scientist Oncology

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join an Oncology Clinical Science team supporting an ongoing Phase I/II solid tumor clinical study evaluating targeted therapies, immunotherapies, and chemotherapy combinations. You will provide scientific oversight, contribute to patient-level data review, support study deliverables through database lock and Clinical Study Report (CSR) activities, and collaborate with cross-functional teams to ensure high-quality study execution.

Key Responsibilities

Job Skills

View the job post & apply

Senior Clinical Scientist Immunology

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

Key Responsibilities

Job Skills

View the job post & apply

Clinical Scientist Rare Disease

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join a dynamic and ambitious team.

Main Responsibilities:

Job Skills

View the job post & apply

Clinical Scientist Immunology

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

Key Responsibilities

Job Skills

View the job post & apply

Senior Medical Writer

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents).

The Medical Writer will draft the reference documents for clinical studies, other research involving the human person and research not involving the human person and which must be part of the authorization request file from the Competent Authorities, such as the protocol, the summary of the protocol, the information and consent form, the observation booklet and any patient questionnaires and the investigator brochure.

The Medical Writer will work alongside healthcare professionals, project managers, statisticians and other company functional groups to produce the medical writing deliverables.

Main Responsibilities:

 

Job Skills

View the job post & apply

Clinical Scientist Oncologie

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

About You

Job Skills

View the job post & apply

Clinical Scientist

posted by: spj_bot

About the Job

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

Job Skills

View the job post & apply

Scientifique PKPD

posted by: spj_bot

About the Job

Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.

Key Responsibilities:

Job Skills

View the job post & apply

Clinical Research Director

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Clinical Research Director for Inflammation and Immunology (I&I), you will lead critical clinical programs and play a pivotal role in advancing innovative therapies for patients.

This remote role empowers you to influence clinical strategy significantly, ensuring that we not only meet regulatory standards but also create optimal study designs that translate into successful patient outcomes.

Main Responsibilities:

Lead the clinical development of projects in the Inflammation and Immunology therapeutic area from inception through to the successful execution of clinical trials

Ensure compliance with regulatory requirements, ICH-GCP principles, and internal procedures throughout the trial lifecycle

Develop and approve key clinical documents including protocols, informed consent forms, and study amendments

Work closely with cross-functional teams to define clinical strategy, operational processes, and delivery timelines

Serve as the primary medical and scientific contact for Health Authorities, Ethics Committees, investigators, and key stakeholders

Oversee and guide the design, governance, and conduct of clinical committees, ensuring adherence to governance standards

Job Skills

View the job post & apply
Subscribe to clinical study report

SPJ is not just a platform; it's a transformative force in the maritime sector. We reinvent job discovery and collaboration, leveraging cutting-edge AI to create a space where careers thrive and innovations set sail.

Featured Posts