Associate Director, Biostatistics

at  BioNTech AG

Schleswig-Holstein, Schleswig-Holstein, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate12 Feb, 2025Not Specified12 Nov, 2024N/AGood communication skillsNoNo
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Description:

JOIN OUR TEAM OF PIONEERS!

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.

HOW TO APPLY:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

  • Only applications sent via our online form shall be considered.
  • Only Candidates with the right qualifications and relevant experience shall be shortlisted and
  • Incomplete applications shall be rejected.
  • Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
www.biontech.co

Responsibilities:

  • 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.
  • Mentor (Associate) Directors and/or Line management of GBS staff in the China team.
  • 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 due diligence projects for business partnerships and serve as contact person in Biostatistics for external partners for assigned studies.
  • Keep updated on development of new Chinese regulatory guidelines, statistical methodologies and technologies and serve as SME in Statistics for clinical development.
  • 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.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Phd

Proficient

1

Schleswig-Holstein, Germany