Become a member of the BioNTech Family! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. 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 Open for hire at one of the following locations - Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 4414 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 Experiences in planning, conducting and analyses of oncology or infectious diseases 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 behaviours Very good communication skills: the ability to express complex analysis in clear language an excellent command of English (written and 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. Click here to find out more about what we do, the careers we offer and also the benefits we provide. 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.
