Senior Director, Biostatistics (Oncology)

BioNTech•Gaithersburg, MD

23h

About The Position

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)

Requirements

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)
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)

Nice To Haves

Very deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus

Responsibilities

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

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 subsidized parking
Discounted Home, Auto & Pet Insurance