Statistical Lead - Munich, Deutschland - ITM Isotope Technologies Munich SE

ITM Isotope Technologies Munich SE

Geprüftes Unternehmen

Munich, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Your Role:

Member of the medical team, with key role leading the biostatistics activities for clinical development (Phase I to Phase IV)
Responsible for providing all statistical inputs for study design, outcome measurement, data collection, endpoint assessment, sample size and power calculation, including coordinating external statistician expert input when needed
Anticipating, identifying and resolving statistical issues proactively with the support of the project team
Ensure appropriate communication of statistical information and results internally and externally
Responsible for statistical sections of clinical trial protocols, clinical study reports and regulatory modules
Accountable for the quality control and oversight of biostatistics vendor deliverables, when statistical analyses are outsourced
Accountable for statistical analysis plans, analysis dataset specifications and programing, as well as tables, figures and listings specifications and programing
Participate in setting up the internal crossfunctional biometry team including contributing to the recruitment of statistician and programmers and to building the quality assurance system and procedures for internal and external biostatistics activities

What we are looking for:

Biostatistician, PhD preferred
5+ years of biostatistics professional experience, preferably in pharmaceutical industry or CRO, experience in oncology clinical trials would be a strong asset
Solid experience in managing frequentist as well as Bayesian biostatic activities, from concept to analysis programing and results interpretation
Solid background in the development of Phase I to Phase III clinical study protocols and statistical analysis plan including sound knowledge of new methodologies and designs such as basket studies, BOIN 1/2 dose finding design, interim analysis, etc.
Sound knowledge of CDISC, ICH-GCP and other relevant regulations/guidelines
R and/or SAS programing skills for data formatting and data analysis
Experience in interacting with regulatory authorities
Demonstrated expertise in ability to lead complex scientific discussions and synthesize and communicate information clearly
Demonstrated leadership experience, with ability to work in a mediumsize company with a matrix environment
Professional proficiency in both spoken and written English

What we offer:

A modern workplace and exciting opportunities in an evolving and fast growing company
Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
A collegial corporate culture and short communication channels
Flexible working hours with an attractive salary package and diverse corporate benefits

At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.

Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than "maybe".

Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?

Then send us your detailed CV including earliest start date and salary expectations in English language. The position is intended for the ITM Oncologics GmbH, a company of the ITM group.