BioNTech SE
Senior Director, Biostatistics (Oncology)
Location: Cambridge, US; Gaithersburg, US; New Jersey, US. Job ID: 9895. Full time.
Responsibilities
Represent Statistics in all assigned cross‑functional clinical study teams and hold accountability 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, infrastructure initiatives, and evaluations.
Work as part of a collaborative, cross‑functional team with members from other disciplines.
Provide statistical guidance into clinical development plans, protocols, 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, develop associated documents, and prepare associated responses.
Oversee outsourced statistical CRO activities and deliverables, ensuring highest quality and timeliness.
Support and participate in the development of departmental strategies and cross‑functional initiatives on standards, infrastructure, and processes.
Support and assist GBS Lead in both strategy development and operations.
Assume possible line‑management responsibilities of staff and be responsible for recruiting, developing, and retaining talent.
Provide guidance to Statistical Programmers on SDTM/ADaM and TLF specifications development and programming.
Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met.
Qualifications
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 representing Biostatistics in a matrix organization and multidisciplinary team.
Experiences in planning, conducting and analysing Infectious Diseases trials from phase I‑IV, including scientific publications.
Experience in leading to answer health authority questions (FDA, EMA) and leading 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 analyse complex issues to develop relevant and realistic plans, programmes, recommendations, risk mitigation strategies, and to communicate them to cross‑functional colleagues.
Strong drive for achieving high‑quality working results in a timely manner while safeguarding ethical standards.
Excellent communication skills: the ability to express complex analysis in clear language; excellent command of English (written and spoken).
Pay Expected Pay Range: $260,000/year to $320,000/year + benefits, annual bonus & equity (bonus and equity are variable and dependent on company and individual performance). Compensation will depend on several factors including responsibilities, education, experience, knowledge, skills, and abilities.
Benefits
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 subsidised parking
Discounted Home, Auto & Pet Insurance
Additional Information 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.
Application Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US locations 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.
We look forward to your application!
#J-18808-Ljbffr
Responsibilities
Represent Statistics in all assigned cross‑functional clinical study teams and hold accountability 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, infrastructure initiatives, and evaluations.
Work as part of a collaborative, cross‑functional team with members from other disciplines.
Provide statistical guidance into clinical development plans, protocols, 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, develop associated documents, and prepare associated responses.
Oversee outsourced statistical CRO activities and deliverables, ensuring highest quality and timeliness.
Support and participate in the development of departmental strategies and cross‑functional initiatives on standards, infrastructure, and processes.
Support and assist GBS Lead in both strategy development and operations.
Assume possible line‑management responsibilities of staff and be responsible for recruiting, developing, and retaining talent.
Provide guidance to Statistical Programmers on SDTM/ADaM and TLF specifications development and programming.
Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met.
Qualifications
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 representing Biostatistics in a matrix organization and multidisciplinary team.
Experiences in planning, conducting and analysing Infectious Diseases trials from phase I‑IV, including scientific publications.
Experience in leading to answer health authority questions (FDA, EMA) and leading 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 analyse complex issues to develop relevant and realistic plans, programmes, recommendations, risk mitigation strategies, and to communicate them to cross‑functional colleagues.
Strong drive for achieving high‑quality working results in a timely manner while safeguarding ethical standards.
Excellent communication skills: the ability to express complex analysis in clear language; excellent command of English (written and spoken).
Pay Expected Pay Range: $260,000/year to $320,000/year + benefits, annual bonus & equity (bonus and equity are variable and dependent on company and individual performance). Compensation will depend on several factors including responsibilities, education, experience, knowledge, skills, and abilities.
Benefits
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 subsidised parking
Discounted Home, Auto & Pet Insurance
Additional Information 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.
Application Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US locations 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.
We look forward to your application!
#J-18808-Ljbffr