Senior Director, Biostatistics (Oncology)

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9895

Your main responsibilities are:

• Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects
• Serve as the biostatistics lead core team member for all assigned programs
• Represent Statistics in multiple projects of cross-functional process and standards development/ improvements, and infrastructures initiatives and evaluations
• Work as part of a collaborative, cross-functional team with members from other disciplines
• Provide statistical guidance 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
• 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
  
  

What you have to offer:

• 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
• Experiences in planning, conducting and analyses of 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)
• Very deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
• Outstanding 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
• 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 and spoken)
  

Expected Pay Range: $260,000/year to $320,000/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; Gaithersburg, 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.