Director Biostatistics (Oncology)

BioNTech

1d•Onsite

About The Position

As Director of Biostatistics you will represent Statistics in all assigned cross-functional clinical study teams and other projects and hold yourself accountable for all statistical aspects. You will serve as the biostatistics lead core team member for all assigned programs and provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.

Requirements

PhD or Masters in (Bio)Statistics, Mathematics or equivalent
Minimum 10 years (13 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 or infectious diseases trials from phase I-IV, including scientific publications
Experience in leading to health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
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 or R) and sample size calculation software (e.g., EAST and/or NQuery)
Excellent analytical skills and 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
Excellent communication skills: the ability to express complex analysis in clear language
an excellent command of English written spoken

Nice To Haves

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

Responsibilities

Work as part of a collaborative, cross-functional team with members from other disciplines
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, and cross functional initiatives on standards/ infrastructures/ processes
Assumes possible line management responsibilities of junior staff and is responsible for recruiting, developing, and retaining talent
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