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BioNTech SE · 9 hours ago

Director Biostatistics (Oncology)

Cambridge, MA

Full-time

Onsite

Director/Executive

$220K/yr - $265K/yr

8+ years exp

BioNTech SE is seeking a Director Biostatistics (Oncology) to collaborate with clinical development partners and oversee statistical analysis standards. The role involves providing statistical support for clinical trials, mentoring junior staff, and ensuring high-quality deliverables in a fast-paced environment.

Health Care

Responsibilities

Provide statistical support and leadership for assigned clinical trials and programs in accordance with company objectives

Oversee and give statistical guidance on trials within a program or platform

Train and guide GBS colleagues as an SME in special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA or RWE/ epidemiology

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

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

Serve as lead contact person in Biostatistics for external partners for assigned studies

Support and participate in initiatives to develop, implement and improve standards, processes and infrastructure

Keep updated on development of new statistical methodologies and technologies

Mentors Associate Directors or less experienced Directors and assumes possible line management responsibilities of junior staff and is responsible for recruiting, developing, and retaining talent

Qualification

PhDMasters in StatisticsOncology trial experienceStatistical analysis softwareClinical development knowledgeAdvanced statistical methodsLeadership experienceAnalytical skillsInterpersonal skillsTeamworkFlexibility

Required

PhD or Masters in (Bio)Statistics, Mathematics or equivalent

Minimum 8 years (10 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 trials from phase I-IV, including scientific publications

Experience in supervision of outsourced activities as well as with the development and execution of outsourcing strategies

Very good knowledge and experience of clinical development, study designs, advanced statistical methods, regulatory guidelines (ICH, FDA, EMA)

Very good knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e.g., EAST and/or NQuery)

Excellent 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

Excellent interpersonal skills, strong teamwork spirits to develop good working relationships with key stakeholders

Ability to thrive working in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient