Associate Director* Statistical Programming

  • BioNTech Careers
  • Cambridge, Massachusetts
  • Work experience
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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.

Associate Director* Statistical Programming

In this position you will work closely with Director Statistical Programming to implement global statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency

Your main responsibilities are:
  • Support the development and implementation of a global programming ecosystem to enable successful project deliverables
  • Participate in the development and implementation of BioNTech’s centralized data warehouse
  • Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables
  • Establish innovative solutions to standardize, automate and optimize efficiency and quality to meet business needs and meet regulatory requirements
  • Set up tools for efficient verification of derived datasets, e.g. SDTM and ADaM, and TLFs
  • Generate ad hoc data sets and TLFs on ongoing basis
  • Author and review programming specifications and validation
  • Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools and work together with cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and others to meet project deliverables and timelines for statistical data analysis and reporting

What you have to offer.

  • BSc or MSc in Statistics, Mathematics, Computer Science or related subject
  • 6 years of experience in a pharmaceutical industry, CRO or another clinical research setting
  • Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
  • Solid understanding of FDA, EMA, ICH, and global regulations and guidelines as well as strong knowledge of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
  • Substantial awareness of the drug development process from early- to late-stage development and submission
  • Expertise in the requirements and technology required to support electronic submissions
  • Experience in leading submissions and managing people

Benefits for you.

  • 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 onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance                                                                                                       …And much more!

Have we kindled your pioneering spirit?

Then apply now for our Cambridge, MA location 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 8106 #DCA-LI (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