Senior Director Biostatistics (Oncology)

BioNTech

1d • Onsite

About The Position

As Senior Director of Biostatistics, you will represent Statistics in all assigned cross-functional clinical study teams and other projects. You will be accountable for all statistical aspects as well as serve as the biostatistics lead core team member for all assigned programs representing Statistics in multiple projects of cross-functional process and standards development/improvements, infrastructure initiatives and evaluations.

Requirements

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• Minimum 15 years (18 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
• Experience in planning, conducting and analyses of oncology or infectious diseases 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
• 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 or R) and sample size calculation software (e.g., EAST and/or NQuery)
• Outstanding 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

• adaptive design and/or Bayesian is a Plus
• Very deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus

Responsibilities

• Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• 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
• Support and assist GBS Lead in both strategy developments and operations
• Assumes possible line management responsibilities of 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

Benefits

• benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance)
• competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree