Director Biostatistics; Oncology

Join to apply for the Director Biostatistics (Oncology) role at BioNTech SE

Cambridge, MA | full time | Job

• PhD or Masters in (Bio)
  Statistics, Mathematics or equivalent
• Minimum 8 years (10 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 representing Biostatistics in a matrix organization and multidisciplinary team
• Experiences in planning, conducting and analyses of oncology trials from phase I-IV, including scientific publications
• Experience in supervision of outsourced activities and in the development and execution of outsourcing strategies
• Very good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a plus), regulatory guidelines (ICH, FDA, EMA)
• Very good knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e.g., EAST and/or NQuery)
• Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology; a plus
• Excellent analytical skills; ability to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and to communicate them to cross‑functional colleagues
• Excellent interpersonal skills, strong teamwork spirit to develop good working relationships with key stakeholders
• Ability to thrive working in a fast‑paced environment while remaining flexible, proactive, resourceful, and efficient
• Excellent communication skills:
  • The ability to express complex analysis in clear language
  • An excellent command of written and spoken English

• Provide statistical support and leadership for assigned clinical trials and programs in accordance with company objectives.
• Oversee and give statistical guidance on trials within a program or platform.
• Train and guide GBS colleagues as an SME in special topics:
  Diagnostics, Biomarker, PK/PD, PRO, AI, HTA or RWE/epidemiology.
• Provide statistical input into clinical development plans, protocols, reports, regulatory submission documents, and publications ensuring accurate deliverables.
• Perform and/or verify sample size calculations. Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results.
• Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses.
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and timely completion.
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met.
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
• Serve as lead contact person in Biostatistics for external partners for assigned studies.
• Support and participate in initiatives to develop, implement and improve standards, processes and infrastructure.
• Keep updated on development of new statistical methodologies and technologies.
• Mentor Associate Directors or less experienced Directors and assume possible line‑management responsibilities of junior staff, recruiting, developing, and retaining talent.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which are determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note:

The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the use of our benefits are based on the company's internal policies and applicable law.

Apply now by sending us your application documents including Curriculum Vitae, copy of , copies of degree certificates and professional certificates, motivation letter, as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘Hire Right’. You will be informed accordingly by your BioNTech recruiter.

We look forward to receiving your application.