Principal Statistical Programmer*

  • Cambridge, Massachusetts
  • Mainz
  • Work experience
  • Research, development, teaching
scheme imagescheme imagescheme image

Become a member of the BioNTech Family!

As a part of our team of more than 2.500 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.

Principal Statistical Programmer*

The Principal Statistical Programmer of Statistical Programming is responsible for all statistical programming aspects of one or more clinical trials of drug development plans.  The position is ensuring that drug development plans are executed efficiently with timely and high quality deliverables. It is a  blend of highly technical and leadership role with a strong understanding of the drug development process, experience in regulatory activities.


Responsibilities:
  • Collaborate closely with cross-functional teams, including but not limited to Biostatistics, Clinical Data Management, Clinical Operations, Drug Safety, Medical Writing, and Regulatory Affairs to ensure operational excellence. 
  • Coordinate, manage, and prioritize the day-to-day activities in a fast-paced environment.   Train and mentor junior programmers. 
  • Comply with the company, function,  CDISC standards, and ICH guidelines.  
  • Responsible for development, validation, and delivery of high-quality audit-ready statistical programming deliverables.
  • In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, ARM, etc.), eCTD, and regulatory agency (FDA, EMA, PMDA) requirements. 
  • Support NDA/BLA filings, including ISS and ISE.
  • Experience in working with CROs and external vendors for an outsourced clinical study.
  • Lead statistical programming process improvements and department initiatives.  Develop global macros and tools to improve the efficiency of deliverables (example, SDTM, AdaM, and TLFs). 
  • Participate in the development of department programming standards and SOPs to meet business needs and regulatory requirements.

What you have to offer.

What you have to offer
  • Masters Degree in statistics, computer science, mathematics, life sciences or related field with 8+ years of relevant experience or Bachelors Degree in statistics, computer science, mathematics, life sciences or related field with 10+ years of relevant experience
  • Proven expert in SAS language, including Base SAS, macro, SAS/STAT, SAS/GRAPH, and SQL.  R and Python experience is a plus.
  • Solid understanding of regulatory agency (FDA, EMA, PMDA) requirements.
  • Advanced knowledge of CDISC standards. 
  • Advanced understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, ICH) and clinical study practices, procedures, and methodologies.
  • Strong technical leadership and project management skills.

Benefits for you.

  • Medical, Dental, and Vision Insurance
  • Life, AD&D, STD, and LTD Insurance
  • HSA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!
  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 5874 (please indicate for inquiries) #LI-DCA

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de