
Description
Job Details George Higginson is searching for an experienced Statistics Lead, for a privately owned Biotech, based out of Germany. This is a key role within the medical group reporting to the Head of Clinical Development. Within this position, you will be expected to develop and lead the biostatistical activities cross-functionally. Being there first in-house Statistician, you will be overseeing CROs/external vendors and building the in-house function. With this, there will of course be future progression, whereas you will have the freedom to build a team around you.
Responsibilities of the 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 cross-functional 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
Requirements: Biostatistics, 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 medium-size company with a matrix environment Professional proficiency in both spoken and written English
How To Apply: AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies. George Higginson AL Solutions Tel: + (0) 9]