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Principal Biostatistician - FSP Biometrics CRO - Home Office - Germany

Employer
Cytel - EMEA
Location
Germany
Salary
Senior Biostatistican - FSP Biometrics CRO - Home Office Germany
Start date
26 Feb 2019
Closing date
28 Mar 2019

Job Details

Cytel is shaping the future of drug development.

As the world's largest independent clinical biostatistics research and development organization, we help leading pharmaceutical, biotech and medical device companies improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software.

With operations across North America, Europe, and India, we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.

We are experiencing exponential growth on a global scale and expanding our FSP division and hiring Principal  Biostatisticians, adept at utilizing advanced statistical methods,  to lead or help drive one or more Phase I-IV clinical studies supporting a variety of therapeutic areas. 

This position reports to the Director, Biostatistics.

How you will contribute:

  • providing statistical support to clinical studies;
  • 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;
  • 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

What you offer:

  • Master’s degree in statistics or a related discipline. PhD strongly desired.
  • 10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
  • 5+ years (Principal) as a study lead 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 QC of datasets.
  • Submissions experience
  • Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
  • 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

  Why Cytel?

  • Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
  • In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
  • Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

 

 

   

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