Staburo supported PD-L1 assay comparability study

Staburo supported PD-L1 assay comparability study

PD-L1 assay comparability study published

Staburo supported the evaluation of the first multicentric analytical comparability study of PD-L1 expression in urothelial bladder cancer using four clinically developed immunohistochemistry assays. Statistical analyses included the investigation of inter-assay differences using ANOVA and intra-class correlations and the concordance for clinically relevant cut-offs based on Fleiss‘ kappa.

The results suggest that all four currently clinically relevant assays are analytically similar for the evaluation of PD-L1-stained immune cells and three (SP263, 22C3, and 28-8) for PD-L1-stained tumor cells.

The paper, which was recently published in Virchows Archiv, can be downloaded here (Staburo’s Statistics contribution is mentioned in the Acknowledgments): https://rd.springer.com/article/10.1007%2Fs00428-019-02610-z

Data analysis, clinical biostatistics and more.

Staburo Senior Statistical Programmer Munich

Staburo Senior Statistical Programmer Munich

Die Staburo GmbH ist ein Münchner Biostatistikunternehmen, das auf statistische Beratung und Programmierung im Umfeld von klinischen Studien spezialisiert ist. Aufbauend auf unseren 6 Säulen (Klinische Statistik, Translationale Medizin & Biomarker, Pharmakokinetik/-dynamik, Nutzenbewertung, Nichtklinische Statistik und Statistische Programmierung mit CDISC) erarbeiten wir in Projektteams maßgeschneiderte Lösungen.
Unsere Kunden sind renommierte Pharmafirmen (7 der Top 20), CROs und Biotechunternehmen, mit denen wir flexibel und gerne auch vor Ort zusammenarbeiten.

Zur Erweiterung unseres Teams suchen wir zum nächstmöglichen Zeitpunkt zur Festanstellung einen

Senior Statistical Programmer (m/w)

 
Ihre Aufgabengebiete:
  • Auswertung klinischer Studien der Phasen I – IV und Präsentation der Ergebnisse
  • Statistische Programmierung (SAS mit SDTM und ADaM; R)
  • Programmvalidierung von klinischen Studien
  • Spezifikation von Analysedatensätzen
  • SAS Makro Programmierung
  • Ansprechpartner für unsere Mitarbeiter und Kunden
Ihr Profil:
  • Erfolgreich abgeschlossenes Studium im Bereich Statistik, Mathematik, Informatik, Naturwissenschaften oder eine vergleichbare Ausbildung
  • Berufspraktische Kenntnisse in der statistischen Programmierung oder der klinischen Forschung, gutes methodisches Wissen im Bereich klinische Statistik ist ein Vorteil
  • Mehr als 2 Jahre Erfahrung als Statistischer Programmierer mit Verantwortung für klinische Studien
  • Sehr gute EDV Kenntnisse, besonders mit statistischen Analysetools (SAS, R)
  • Schnelle Auffassungsgabe und analytisches Denkvermögen
  • Teamfähigkeit und ein hohes Maß an Eigeninitiative
Was wir Ihnen bieten:

Es erwartet Sie eine abwechslungsreiche, eigenverantwortliche Tätigkeit mit sehr guten Entwicklungsmöglichkeiten. Wir legen großen Wert auf Kommunikation, flache Hierarchien, offene Unternehmenskultur und ein harmonisches Arbeitsumfeld. Unser Standort in München bietet sehr gute Arbeitsbedingungen, moderne Büroräume und eine schnelle Anbindung an den öffentlichen Nahverkehr.

Neugierig geworden?

Dann informieren Sie sich auf unserer Internetseite: www.staburo.de und werden Teil unseres stetig wachsenden Teams!
Wir freuen uns über Ihre vollständigen Bewerbungsunterlagen mit Angabe Ihrer Gehaltsvorstellung. Für eine schnelle Abwicklung des Bewerbungsprozesses bitten wir um eine E-Mail-Bewerbung an: bewerbung@staburo.de.

Hier finden Sie diese Stellenanzeige als PDF Datei.

 

OTTO: an R Shiny App for Standardized Detection of Outliers in Bioassay Development

OTTO: an R Shiny App for Standardized Detection of Outliers in Bioassay Development

R Shiny App for Standardized Detection of Outliers in Bioassay Development

The availability of reliable and sensitive assays is an important building block in the production and quality control of biological products. In the development of such assays, unusual or erroneous measurement results need to be detected, but adjudication by human operators is often inconsistent or prone to bias.

To help overcome this challenge, a Shiny app for the statistical detection of such outliers is being developed at Staburo: the Optimal Tool for Tracking of Outliers (OTTO). Close collaboration with the end users throughout the development process ensures that the statistical outlier detection results are in good agreement with subject matter expert evaluations. In particular, a mixed method approach was chosen which significantly reduced false outlier detection rates, compared to conventional statistical methods.

Thanks to the capabilities of the R Shiny technology, the user interface is intuitive and well suited for everyday use in the lab. Features of the app include application of outlier tests, automatic curve refitting after removal of outliers, and report generation for documentation purposes.

Data analysis, clinical biostatistics and more.

Staburo @ B2Run2019

Staburo @ B2Run2019

Staburo @ B2Run2019 

Team spirit, speed and strength – this time in action! Staburo started again at this year’s B2Run, after the last one in 2018 was canceled due to safety concerns (click here for the story).

With best weather conditions, 30,000 participants from 1,500 Munich companies ran together to finish in the Olympic Stadium. The race track was 6.1km long and took us through the picturesque 1972 Olympic Park, which alone was worth the effort. Staburo was in the middle of the action, and once again no. 1 in the Biostatistics category, check this graph for our results:

Everyone finished safely (after being cheered on, by great Staburo fans before the finish line) and was greeted and congratulated by the rest of the team. Great achievement!

After some alcohol-free electrolytes, water and fruits, we walked to our beautiful location for dinner, the Italian restaurant “Ciao Francesco” with delicious food.

It was a great evening with sports, fun and dinner!

Data analysis, clinical biostatistics and more.

Staburo Data Manager Munich

Staburo Data Manager Munich

Staburo GmbH is a biostatistics company, specialized in statistical consulting, data management and programming for healthcare projects. Based on our 6 pillars (Clinical Statistics, Translational Medicine & Biomarkers, Pharmacokinetics/-dynamics, Health Technology Assessment, Non-clinical Statistics and Statistical Programming with CDISC), we develop tailor-made client solutions. Our customers are international pharmaceutical companies (7 of the top 20), CROs and biotech companies, with whom we work on a flexible basis.

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

Data Manager (f/m/d)

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 profile:

  • Studies in data management, medical writing, statistics, mathematics, or a similar direction
  • General knowledge of required tasks, willingness to learn
  • Work experience in CRO or pharma/biotech is a plus
  • Fast comprehension and analytical thinking
  • Teamwork and a high degree of initiative

What we offer you:

You can expect an environment with very good development opportunities. We value communication, flat hierarchies, open corporate culture and a harmonious work environment. Our location in Munich offers very good working conditions, modern office space and fast access to public transport.

Curious?

Check our website: www.staburo.de and become part of our constantly growing team!
We look forward to receiving your application, your electronic short CV would be enough for the beginning. Please send this by e-mail to: bewerbung@staburo.de. We look forward to meeting you soon!

Here you find our jod advertisement in PDF format.