Berlin, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID: 8822
Senior Director Biostatistics (Oncology) Your main responsibilities are:
Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects
Oversee and give statistical guidance on trials within a platform or portfolio
Provide statistical guidance 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
Support and participate in initiatives to develop, implement and improve cross-functional standards, processes and infrastructure initiatives and evaluations
Support and assist GBS Lead in both strategy developments and operations
Mentors (Associate) Directors and/or assumes possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent
Collaborate with Safety and Pharmacovigilance in developing processes and standards to support safety assessment, signal detection and decision making
Provide input into early risk management plan, blinded and unblinded safety monitoring (through internal safety review committees or DMC)
Collaborate with Statistical Programming to ensure the data integration processes
Lead aggregate safety analyses of clinical trials across the BioNTech portfolio
Stay up to date with developing methodologies related to safety analysis and signal detection, including identifying adverse drug reactions per regulatory guidance What you have to offer:
PhD or Masters in (Bio)Statistics, Mathematics or equivalent
Minimum 12 years (15 years for masters) in the pharmaceutical industry and/or CRO
At least 10 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 leading to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages
Experience in leading integrated statistical analyses
Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
Excellent knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e.g., EAST and/or NQuery)
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
Awareness of the bigger picture, strong orientation to quality and timely manner, innovative and solution orientated thinking
Excellent communication skills: ability to express complex analysis in clear language
excellent command of written and spoken English 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.