Principal Biostatistician job in Berlin, Germany

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Statistics

Location: Germany

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a Principal Biostatistician to lead and drive forward Phase I-IV trials. This organisation is dedicated to using talent, experience and integrity to advance the state of clinical development. If you think this role might be for you, then do not hesitate to apply.

Job Responsibilities

participating in the development of study protocols, including participation in study design discussions and sample size calculations;
reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
performing statistical analyses;
interpreting statistical results;
preparing clinical study reports, including integrated summaries for submissions (ISS/ISE);
leading study activities when called upon;
utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
being adaptable and flexible when priorities change

Skills and Requirements

Master's degree in statistics or a related discipline. PhD strongly desired.
8-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
Experience in Early Development studes desired.
3-5 years of Study Lead experience working with cross-functional teams.
Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
Knowledge and implementation of advanced statistical methods.
Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
Strong knowledge of ICH guidelines.
Solid understanding & implementation of CDISC requirement for regulatory submissions.
Adept in ADaM specifications generation and programmatic review of datasets.
Submissions experience (ISS/ISE) strongly desired.
Effective communicator: able to explain methodology and consequences of decisions in lay terms.
Team player; willingness to go the extra distance to get results, meet deadlines, etc.
Ability to be flexible when priorities change and deal with ambiguity

What's in it for you:

You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
You will be part of an exciting new chapter in history with high growth and opportunities to progress in Senior and Leadership positions within the company
Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
Work with and leverage the best and brightest minds in the industry

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI_HH1

Salary

Highly Competitive

Location:

City of London, England

Proclinical is seeking a dynamic Associate Director Outsourcing Operations - Statistics or Programming position for a remote role anywhere within Europe.

Heidi Hennigan

Apply

Associate Director/Director Statistical Consulting

Salary

Highly Competitive

Location:

City of London, England

Proclinical are seeking a dynamic leader with a passion for biostatistics and clinical trial methodologies for an Associate Director/Director Statistical Consulting position.

Heidi Hennigan

Apply

Director, Statistical Programming

Salary

US$180000 - US$210000 per annum + Highly Competitive Salary

Location:

Boston, USA

Proclinical is actively seeking a Director of Statistical Programming for a global biotechnology company. This is a permanent role with the opportunity to work remotely.