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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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