Director Biostatistics (Oncology)

BioNTech SE•Cambridge, MA

65d

About The Position

As Director Biostatistics (Oncology) you will collaborate with strategic clinical development partners in harmonizing statistical analysis standards and to review all stats-related documents for partners sponsored studies. Moreover, you will oversee/coordinate the collaborated IIT studies and act as representative for Statistics in all assigned cross-functional clinical study teams and other projects and hold yourself accountable for all statistical aspects.

Requirements

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 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
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)
Excellent 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
Excellent interpersonal skills, strong teamwork spirits 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

Nice To Haves

Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology, is a plus
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)

Responsibilities

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 like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA or RWE/ epidemiology
Provide statistical input into clinical development plans, clinical study protocols, clinical study 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 in a timely manner
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
Mentors Associate Directors or less experienced Directors and assumes possible line management responsibilities of junior staff and is responsible for recruiting, developing, and retaining talent

Benefits

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 is 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 individual use of our benefits are based on the company's internal policies and applicable law.

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