Clinical Data Standards Developer

1 month ago


Ballerup, Ballerup Kommune, Denmark LEO Pharma AS Full time
About the Role

We are seeking a highly skilled Clinical Data Standards Developer to join our team at LEO Pharma A/S.

As a Clinical Data Standards Developer, you will play a vital role in maintaining and further developing our clinical data standards, including SDTM, ADaM, and TFL standards.

Your primary responsibility will be to develop and maintain programming solutions, such as standard SAS macros, APIs, tools to support the analysis and reporting of clinical trial data across various trials and clinical development projects.

Key Responsibilities
  • Develop and maintain programming solutions for clinical trial data analysis and reporting.
  • Act as a superuser, providing day-to-day support to end-users of our Statistical Computing Environment and our analysis and reporting standards.
  • Ensure end-user training and assist with IT-related tasks, such as system upgrades.
  • Identify and address the needs of different stakeholders, including data management, statistical programming, biostatistics, and medical writing, providing input for prioritization.
  • Support the technical implementation and adoption of clinical data standards.
  • Drive the adoption of clinical data standards from external organizations like CDISC and regulatory authorities.
Requirements
  • Graduate qualification in mathematics, statistics, computer science, life sciences, or a related field, or equivalent work experience.
  • Strong proficiency in SAS programming.
  • Ability to develop and leverage SAS macros for efficient and scalable programming, automating repetitive tasks, and integrating with other systems.
  • Strong knowledge of CDISC standards and regulatory requirements.
  • Familiarity with handling and analyzing clinical trial data.
  • Excellent attention to detail and accuracy.
  • Good communication and interpersonal skills.
  • Positive mindset and ability to foster good collegial relations.
  • Ability to work both independently and collaboratively in a team environment.
Compensation and Benefits

We offer a competitive salary of approximately $95,000 per year, commensurate with experience.

In addition to a comprehensive benefits package, we offer ample opportunities for growth and professional development.



  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking an experienced Data Management Expert to join our team in Novo Nordisk A/S's Research Data Management department. The successful candidate will be responsible for managing non-clinical data flows, ensuring high-quality project deliverables, and collaborating with internal and external partners.About the RoleThe Senior Data Manager...

  • Clinical Audiologist

    4 weeks ago


    Ballerup, Ballerup Kommune, Denmark GN Group Full time

    At the GN Group, we are seeking an experienced Clinical Audiologist to join our team in Ballerup, Denmark. This is a unique opportunity to contribute to the development of innovative hearing solutions that enhance people's lives.About the RoleThis role will involve evaluating hearing aids and fitting software, conducting testing and data analysis, and...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    We are seeking an experienced Translational Medicine Lead to join our team at Novo Nordisk. This role will be a key part of our efforts to develop and deploy pharmacodynamic biomarkers in Phase 1 trials, working closely with multi-disciplinary teams to ensure translational medicine biomarkers are integral from early research experiments through to clinical...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the Role:We are seeking an experienced Lead Clinical Supplies Operations Manager to join our dynamic team at Novo Nordisk. As a key member of our Clinical Supplies Development department, you will play a crucial role in ensuring the smooth operation of clinical trials.Key Responsibilities:Provide strategic leadership and direction to the Clinical...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About Clinical SuppliesClinical Supplies is a key function within Novo Nordisk, responsible for delivering drugs for the company's clinical trials worldwide. Our tasks range from receiving clinical protocols to final delivery of clinical products at trial sites, including planning, labeling, packaging, and shipping.Our processes involve numerous steps and...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Are you a skilled professional seeking an exciting opportunity to contribute scientifically and strategically to research and early development? We are looking for a talented Senior Clinical Pharmacology Strategist to drive first-in-human activities across therapeutic areas.The PositionAs a Senior Clinical Pharmacology Strategist, you will be responsible for...

  • Data Scientist

    1 month ago


    Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    Transformative data engineering opportunities await at Ambu, a global leader in medical device solutions. As a Data Engineer, you will be at the forefront of revolutionizing patient care through cutting-edge data platforms in Microsoft Azure.In this pivotal role, you will spearhead the automation of business processes through digitalization, playing a...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Are you passionate about driving change and making a tangible impact on operations?We are seeking an experienced Project Manager to join our Clinical Supplies team at Novo Nordisk A/S.About the RoleAs a Project Manager in Clinical Supplies, you will lead projects to optimize and digitalize processes, negotiating resources with line managers and managing...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Overview">The Research Data Steward and Data Governance Expert will play a crucial role in ensuring the quality and consistency of data at Novo Nordisk A/S. As part of the Data Representation department, this position will be responsible for managing pre-defined domains of master data and metadata groups.">About the Role">In this role, you will collaborate...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly skilled Data Management Expert to join our team at Novo Nordisk A/S. As a Research Data Steward, you will play a critical role in ensuring the quality and consistency of our data, driving change management, and influencing the adoption of standardized vocabulary.Key Responsibilities:Work closely with diverse...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking an experienced Industrial Operations Specialist to join our Clinical Supply Chain team at Novo Nordisk A/S. This role will be responsible for managing and validating GxP equipment/systems, ensuring the growth of the business while maintaining patient safety.About the PositionThe successful candidate will oversee upgrades, rebuilds,...

  • Data Engineer

    4 weeks ago


    Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    We are on a transformative journey, establishing a new foundation of processes, ownership, and technology, with a major focus on developing a cutting-edge Data Platform in the Microsoft Azure cloud.As a Data Engineer at Ambu A/S, you will be at the forefront of automating business processes through digitalization and playing a pivotal role in our strategic...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a Senior Research Data Governance Strategist to join our team at Novo Nordisk A/S.About the RoleIn this key position, you will develop and execute a comprehensive research data governance strategy, aligning with regulatory requirements and industry best practices.Main ResponsibilitiesDevelop and Implement a Comprehensive Data...


  • Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full time

    Unlock Your Potential in Antibody DevelopmentAbout the Role:We are seeking a highly skilled and experienced professional to lead our Purification team as Team Manager Purification. As a key member of our development team, you will be responsible for driving innovation and excellence in antibody-based therapeutic products.Your Key Responsibilities:Develop and...


  • Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    Are you passionate about driving technological innovation in the healthcare industry? Do you want to play a pivotal role in enhancing patient care and data-driven decision-making at Ambu A/S?About the RoleWe are seeking a highly skilled Senior Data Platform Engineer to join our Data and Analytics department at Ambu's headquarters. As a key member of our...


  • Ballerup, Ballerup Kommune, Denmark Jabra Full time

    About UsJabra, a part of GN, is an international organization with colleagues in over 50 different countries.Job OverviewWe are currently seeking a Data Solutions Architect to join our Business Intelligence (BI) team. The successful candidate will be responsible for defining and developing BI and analytics solutions across our Enterprise division at...

  • Data Architect

    2 months ago


    Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Data Architect to lead our Digital Data & IT Product Supply Architecture Team in delivering a future-proof and solid IT architecture.As a Domain Architect, you will be responsible for defining, driving, and maintaining the Data architectural runway, ensuring a harmonized and standardized Architecture together...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Data Integrity Steward to join our team at Novo Nordisk A/S. As a Data Integrity Steward, you will play a crucial role in ensuring the accuracy and reliability of our data across various teams and departments.Key Responsibilities:Establish and maintain data flow maps and data integrity risk assessments to ensure...


  • Ballerup, Ballerup Kommune, Denmark Symphogen Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at Symphogen, a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology.Job SummaryThe successful candidate will be responsible for further developing and maintaining the Quality System, including international...


  • Ballerup, Ballerup Kommune, Denmark emagine Consulting Full time

    emagine Consulting is seeking a Data Science Expert to support our client in the pharmaceutical industry. The ideal candidate will have strong data science skills and experience working with Python.About the RoleThe successful candidate will be responsible for developing training content for Pharmaceutical Data Science targeted at Python coders, creating...