Director Biostatistics

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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.

Director Biostatistics

Primary responsibilities include:
  • Serve as the biostatistics lead core team member for all assigned programs and holds him/herself accountable for all statistical aspects. Represent biostatistics in cross-functional project and study teams on multiple projects
  • Work as part of a collaborative, cross-functional team with members from other disciplines.
  • Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
  • Generate and/or verify sample size calculations and randomization schemes as needed. Lead development of statistical analysis plans and TLF development and performing statistical analyses and validate analysis results using SAS or R software
  • Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
  • Be responsible for vendor management & oversee outsourced statistical CRO activities and deliverables ensuring highest quality
  • Support and participate in the development of departmental strategies. Develop, improve, and implement statistical processes and standards
  • Ensures operational and functional excellence, constantly evaluating and implementing new technologies, and leveraging state-of-the-art data analysis tools
  • Assumes possible line management responsibilities of junior 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

What you have to offer.

• Minimum ten years (12 years for masters) in the pharmaceutical industry and/or CRO
• At least 5 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team • Experiences in planning, conducting and analyses of oncology trials from phase I-IV, including scientific publications
• Experience in supervision of outsourced activities as well as with the development and execution of outsourcing strategies
• Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions​​​​​​
• Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
• Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus 
• Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking 
• Ability to thrive working in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient 
• Excellent interpersonal skills. Ability to develop strong working relationships with key stakeholders. Good conflict management and negotiation skills 
• Outstanding analytical skills. Ability to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues 
• Strong drive for achieving high quality working results, while always safeguarding ethical standards in work and behaviors 
• Mindset of precision and high-quality standards, going beyond the obvious to deliver high-quality analyses and support in a challenging and evolving environment 
• Above-average communication skills: 
  • the ability to express complex analyses in clear language
  • an excellent command of English written spoken

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 more!

Have we kindled your pioneering spirit?

Then apply now for our 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 7558 (please indicate for inquiries) #DCA-LI

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

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