BioNTech IMFS
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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
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.
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
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, USlocation 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.
Inspired? Become part of #TeamBioNTech. 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, encouragecreativity, 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!
#J-18808-Ljbffr
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
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.
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
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, USlocation 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.
Inspired? Become part of #TeamBioNTech. 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, encouragecreativity, 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!
#J-18808-Ljbffr