Principal Statistical Programmer*

  • Cambridge, Massachusetts
  • Work experience
  • Research, development, teaching
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Become a member of the BioNTech Family!

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

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:
The primary  responsibilities will include but not limited to:
  • 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.

  • 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.

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HRA & 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
  • Plus more benefits that will be shared upon hire!

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 #LI-DCA (please indicate for inquiries)

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