Associate Director, Statistical Programming

at  BioNTech AG

Schleswig-Holstein, Schleswig-Holstein, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate12 Feb, 2025Not Specified13 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:

  • Engage with and provide oversight to our CRO partners in China to achieve high quality and timely deliverables.
  • Supervise outsourcing/insourcing statistical programming activities and ensure the implementation per BioNTech standards and strategy.
  • Independently perform or oversee the production and/or validation of programming. deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries.
  • Ensure quality control (QC) performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements.
  • Support the development and implementation of a global programming ecosystem to enable successful project deliverables.
  • Work collaboratively with Clinical Development team to meet project deliverables and timelines for statistical data analysis and reporting.
  • Participate in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios; develops tools for efficient production and verification of derived datasets, e.g. SDTM and ADaM, and TLFs.
  • Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools.
  • Provide programming support to the global regulatory submissions including data submission package and define.xml development.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

BSc

Computer Science, Mathematics, Statistics

Proficient

1

Schleswig-Holstein, Germany