Staburo @ CDISC 2021 Europe Interchange

Staburo @ CDISC 2021 Europe Interchange

Staburo @ CDISC 2021 Europe Interchange 

Data standards are of vital importance to transparent, high quality, efficient analysis and decision-making in all stages of clinical (and preclinical) research. Staburo was represented at the Clinical Data Interchange Standards Consortium (CDISC) 2021 Europe Interchange virtual conference, which took place from 28-30 April, to keep track of the latest developments in the field. Among the major themes of the conference were the integration of the data standards environment (e.g. CDISC, HL7 FHIR, OMOP Common Data Model), the implementation of the “biomedical concepts” approach in CDISC, and automated metadata processing and utilisation (e.g. via metadata repositories such as the CDISC Library). Besides the discussion of new technical developments, the presentations included case studies, showcasing of educational material and software tools, and regulatory perspectives. The challenges posed by the Covid19 pandemic were given special attention, including a presentation on the current status of vaccine development by the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks.

Data analysis, clinical biostatistics and more.

Disclosure & Posting Manager (f/m/d) (BSc/MSc)

Disclosure & Posting Manager (f/m/d) (BSc/MSc)

Staburo GmbH is a data science company, specialized in statistical consulting, programming and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency, Health Technology Assessment and Bioinformatics. Our customers are international pharmaceutical companies (7 of the top 20), CROs, biotech companies and medical device manufacturers. Our steadily growing team of 45 experts supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results.

To expand our team in Munich, we are looking for a

Disclosure & Posting Manager (f/m/d) (BSc/MSc)

Your responsibilities will include:
  • Identify disclosure-relevant studies within Clinical Trial Management System
  • Review study protocols/amendments for disclosure readiness and provide feedback,
    ensure compatibility with registry format and content requirements
  • Prepare study data for registration
  • Resolve all study data-related issues with sponsor teams
  • Coordinate approvals for public posting with client
  • Timely submission of registrations
  • Timely update of registry records (incl. protocol amendment information)
  • Resolution of registry NIH QA comments
Your Profil:
  • Bachelor’s or Master’s degree in data management, medical writing, statistics, mathematics, or a similar field of study
  • General knowledge of required tasks, willingness to learn
  • Work experience in CRO or pharma/biotech is a plus
  • Fast comprehension, analytical thinking, teamwork and a high degree of initiative
What we offer you:

As a quality provider of statistical consulting we truly believe that delivery of high-quality services is the foundation of our stable and growing team. Therefore, we give you time for your core job competencies by minimizing organizational burden. Our continued trainings keep you up to date on all regulatory requirements. We value communication, flat hierarchies, open corporate culture and a harmonious work environment. We offer comprehensive individual development opportunities and flexible working hours.

Curious?

Check our website: www.staburo.de and become part of our constantly growing team!
Please send your application by e-mail to: bewerbung@staburo.com. We look forward to meeting you soon!

Here you find our job advertisement in PDF format.

 

Head of Quality Assurance (f/m/d) (part-time)

Head of Quality Assurance (f/m/d) (part-time)

Staburo GmbH is a data science company, specialized in statistical consulting, data science and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency, Health Technology Assessment and Bioinformatics.  Our customers are international pharmaceutical companies (7 of the top 20), CROs, biotech companies and medical device manufacturers. Our steadily growing team of 45 experts supports our clients efficiently from study design to data analysis and finally the disclosure and posting of trial results.

To expand our Munich team, we are looking for a

Head of Quality Assurance (f/m/d) (part-time)

Your areas of responsibility:

  • You define and implement the strategy and goals of quality assurance (QA) in the company, in accordance with applicable regulatory requirements (e.g. EMA, FDA)
  • You lead the QA team, plan, manage and monitor all QA activities
  • You are responsible for controlled QA documents and regular training
  • You plan and carry out internal and external audits
  • You represent QS in meetings with the management and communicate compliance strategies and risks

Your profile:

  • Completed degree with a focus on quality management, health sciences or comparable degree
  • At least 2 years of professional experience in quality assurance and experience with controlled documents (SOPs etc.)
  • Quick comprehension and analytical thinking
  • Precise and accurate way of working
  • Ability to work in a team and a high level of initiative
  • Very good knowledge of English (all QA documents are written in English), German is an advantage

What we offer you:

We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities, continuous trainings, and flexible working hours. A modern and bright office, as well as the opportunity to work from home are part of our everyday working life. You will join an interdisciplinary team allowing you to discuss with and learn from peers with many different backgrounds.

Curious?

Check our website: www.staburo.de and become part of our constantly growing team! We look forward to receiving your complete application documents. Please send this by e-mail to: bewerbung@staburo.de. We look forward to meeting you soon!

Click here for our job advertisement in PDF format.

 

Senior Biostatistician (f/m/d)

Senior Biostatistician (f/m/d)

Staburo GmbH is a data science company, specialized in statistical consulting, data science and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency, Health Technology Assessment and Bioinformatics.  Our customers are international pharmaceutical companies (7 of the top 20), CROs, biotech companies and medical device manufacturers. Our steadily growing team of 45 experts supports our clients efficiently from study design to data analysis and finally the disclosure and posting of trial results.

To expand our team, we are looking for a

Senior Biostatistician (f/m/d)

Your responsibilities will include:

  • Planning studies including sample size calculation
  • Creation of the SAPs and the study designs
  • Evaluation of clinical studies of phases I – IV and presentation of the results
  • Statistical programming (SAS with SDTM and ADaM; R)
  • Program validation of clinical trials
  • Contact person for our employees and customers

Your profile:

  • Successfully completed studies in statistics, mathematics, or comparable studies or PhD
  • Very good methodological knowledge in the field of clinical statistics
  • More than 2 years of professional experience as a statistician with responsibility for clinical studies
  • Very good IT skills, especially with statistical analysis tools (SAS, R)
  • Quick comprehension and analytical thinking
  • Ability to work in a team and a high level of initiative

What we offer you:

We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities, continuous trainings, and flexible working hours. A modern and bright office, as well as the opportunity to work from home are part of our everyday working life. You will join an interdisciplinary team allowing you to discuss with and learn from peers with many different backgrounds.

Curious?

Check our website: www.staburo.de and become part of our constantly growing team! We look forward to receiving your complete application documents. Please send this by e-mail to: bewerbung@staburo.de. We look forward to meeting you soon!

Click here for our job advertisement in PDF format.