Mainz, Germany; Berlin, Germany; London, United Kingdom | full time | Job ID: 8824
Associate Director Biostatistics
Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects
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
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
Support and participate in the development of departmental strategies
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
PhD or Masters in (Bio)Statistics, Mathematics or equivalent
Minimum 5 years (8 years for masters) in the pharmaceutical industry and/or CRO
At least 3 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
Experienced in planning, conducting and analyses of oncology trials from phase I-IV, including scientific publications
Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
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)
Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
Very Good 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 in a timely manner, while always safeguarding ethical standards in work and behaviors
Very good communication skills: ability to express complex analysis in clear language
an excellent command of English written spoken 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.