Cambridge, US; Central Plains, US; Gaithersburg, US; Mid-Atlantic North, US; Mid-Atlantic South, US; New Jersey, US | full time | Job ID: 9895

About this Role:

As Director Biostatistics (Oncology) you will collaborate with strategic clinical development partners in harmonizing statistical analysis standards and to review all stats-related documents for partners sponsored studies. Moreover, you will oversee/coordinate the collaborated IIT studies and act as representative for Statistics in all assigned cross-functional clinical study teams and other projects and hold yourself accountable for all statistical aspects.

Your Contribution:

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

A Good Match:

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 (adaptive design and/or Bayesian is a Plus), 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)
Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology, is a plus
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

Expected Pay Range: $168,100/year to $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Central Plains, US; Gaithersburg, US; Mid-Atlantic North, US; Mid-Atlantic South, US; New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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