Student Internship in Biostatistics: design and analysis of pivotal ophthalmology clinical trials (preferred start 08/2021, 3-5 months)

 

The Position

You will be part of the Data and Statistical Sciences department within Roche Pharma Development located in Basel. As strategic partners in drug development, we apply our drug development and statistical expertise to the creation of clinical development plans, design and analysis of clinical studies, and design and evaluation of non-clinical experiments.

As a statistical intern, you will work as part of an initiative to create best practice guidelines for the design and analysis of Phase 3 ophthalmology trials. Roche runs many clinical trials in ophthalmology to evaluate drugs and potentially gain approval from Health Authorities. There is a high strategic need to define best practices for study design and analysis in order to bring effective medicines to patients more quickly, confidently get rid of ineffective drugs, and reduce costs to society. In order to do this, we need to learn from our successful and failed trials as well as discussions with Health Authorities and external experts. This internship will give you a unique insight into many of the clinical trials we run at Roche as well as our negotiations with Health Authorities.

In this internship, you will work with other statisticians as well as with experts from Regulatory and Clinical Science. You will review and summarise the current practices for the design and analysis for pivotal ophthalmology studies, estimands, and outcomes of Health Authority meetings. For many aspects of study design there will be multiple approaches and Health Authority feedback may be contradictory. You will discuss these aspects with stakeholders and gain further insights from the statistical literature. As part of a team, you will arrive at a consensus position and best practice recommendations for the future. These guidelines will then be rolled out across the ophthalmology organisation. Time permitting, this project could also develop tools (e.g. R programs) to support the design / analysis of ophthalmology trials that integrate with the existing analytical landscape within Roche or develop novel approaches to the design of pivotal study.

Who You Are:

  • You are an enrolled student in or have recently completed an MSc in statistics or a related field or you are at the moment enrolled in a PhD in statistics or a related field

  • You have experience in applied statistics. 

  • You have an interest in clinical trial design as well as the complexity of Health Authority requirements. 

  • Knowledge of the R programming language and mixed models for repeated measures (MMRM) is helpful, but not required. 

  • Previous knowledge of ophthalmology and estimands is not required.  

  • Good written and oral communication in English is essential.

Preferred starting date: August 1, 2022

Workload: 100%

Duration: 3 - 5 months

Have we piqued your interest? Then we look forward to receiving your complete application documents. To be considered please send us your complete application into one PDF including:

  • CV

  • Motivation Letter including desired starting date

  • Include a valid certificate of enrollment or recently completed degree

  • Include a short description of your academic courses and any other relevant experience. Please provide details regarding clinical trial experience, mixed models, and R or other programming languages.

Please note that NON-EU/EFTA nationals have to be constantly enrolled at university during the internship and need to upload with their application a confirmation letter from their university stating that the internship is mandatory for their studies, otherwise the application can't be considered.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

Roche
Roche ist ein globales Unternehmen mit Vorreiterrolle in der Erforschung und Entwicklung von Medikamenten und Diagnostika und ist darauf fokussiert, Menschen durch wissenschaftlichen Fortschritt ein besseres, längeres Leben zu ermöglichen. Roche ist das grösste Biotech-Unternehmen weltweit mit differenzierten Medikamenten für die Onkologie, Immunologie, Infektionskrankheiten, Augenheilkunde und Erkrankungen des Zentralnervensystems. Roche ist auch der bedeutendste Anbieter von In-vitro-Diagnostika und gewebebasierten Krebstests und ein Pionier im Diabetesmanagement. Dank der Kombination von Pharma und Diagnostika unter einem Dach ist Roche führend in der Personalisierten Medizin – einer Strategie mit dem Ziel, jedem Patienten die bestmögliche Behandlung zukommen zu lassen.
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