Senior Director* Biostatistics (Infectious Diseases)

Open for hire at one of the following locations –  Gaithersburg, London, Mainz K1. - Job ID: 5036 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

Senior Director* Biostatistics (Infectious Diseases) 

 

Your main responsibilities are:

 

• Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects
• Serve as the biostatistics lead core team member for all assigned programs
• Represent Statistics in multiple projects of cross-functional process and standards development/ improvements, and infrastructures initiatives and evaluations
• Work as part of a collaborative, cross-functional team with members from other disciplines
• Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform and/or verify sample size calculations
• Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
• Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
• Support and participate in the development of departmental strategies, and cross functional initiatives on standards/ infrastructures/ processes
• Support and assist GBS Lead in both strategy developments and operations
• Assumes possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met

 

What you have to offer:

 

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• Minimum 15 years (18 years for masters) in the pharmaceutical industry and/or CRO
• At least 10 years of work/ leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
• Experiences in planning, conducting and analyses of Infectious Diseases trials from phase I-IV, including scientific publications
• Experience in leading to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages 
• Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/