Global Head of Biostatistics, Biosimilars

Key Skills

Biostatistics, Effective communication skills, R Programming, SAS, Statistical modeling

Job Description

The Biogen Biosimilars Unit (BBU) is committed to commercialization in several biologic categories and product launches. We are a team committed to advancing care for patients needing life changing therapies. As recent industry reports suggest, Biosimilar products in global healthcare have an opportunity to exceed billions of savings during the next five years – Biogen is committed to be at the forefront of this opportunity for patients and the healthcare system.

In this amazing opportunity the incumbent will be accountable for all biostatistics, statistical programming and clinical data management activities and deliverables for a portfolio of Biosimilars in both pre/ post-approval setting.

You will act as a highly visible member of the Biosimilars R&D leadership team and like this represent Evidence Generation in meetings with Executive Committee, Regulatory Bodies or external development partners.You will provide significant input to Clinical Development planning / strategies as well as to regulatory submission aspects.

The position will require you to build strong connections to stakeholders across the company and to position yourself as a trusted and honored leader driving initiatives while aligning with all parties involved. Finally, you will be responsible for managing, developing and growing a team of high performing biostatisticians, statistical programmers and clinical data managers.

Your Responsibilities:

• Lead a team of statisticians, statistical programmers and clinical data managers (5-7 FTEs) within Biosimilars Evidence Generation
• Providing guidance and support for all biostatisticians, statistical programmers and clinical data managers in assigned projects. Development of staff through coaching and training, retaining talents and managing performance
• Providing broader mentoring and guidance to ensure that the Biosimilars Evidence Generation missions and goals are achieved
• Directing overall statistical activities for projects assigned including implementation of efficient, consistent, and practical processes for Biostatistics and monitoring of efficient resource allocation and usage for assigned projects
• Providing guidance and direct input into strategy, planning and contents of clinical development plans as well as key components of regulatory submissions
• Striving to increase the scientific agility by facilitating the implementation of innovative approaches and increasing operational efficiency 
• Serving as the primary functional reviewer/ approver of e.g. CRFs, protocols, analysis plans and clinical study reports
• Providing guidance and direct input in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and representing Biostatistics in key regulatory meetings or meetings with KOLs
• Be accountable for overall quality and accuracy of the deliverables of the Evidence Generation team
• Be accountable for oversight of activities performed by CROs/ external partners
• Oversee the implementation of the data standards and exchange formats across all Contract Research Organizations (CROs) to ensure consistency in collection and reporting of clinical data that they are in an appropriate regulatory required format following CDISC
• Participate in and/or leading of cross-functional initiatives representing Evidence Generation as well as participating in key Biosimilars R&D governance meetings
• Establish and maintain good working relationship within Biosimilars R&D and Innovator R&D teams
• Represent Biogen in statistical forums at conferences or scientific meetings
• Contribution to Due Diligence assessments of biosimilars candidates

Who you are

You are an experienced Biostatistician used to be an active and constructive member of R&D leadership groups. You know well how to balance, challenge and unite different opinions to come up with strong and innovative solutions. You strive to always challenge the status quo in order to deliver excellent and outstanding results to solve complex problems.

Qualifications

Your education & experience

• PhD in Biostatistics/Statistics or equivalent with a minimum of 9-10 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 11-12 years relevant experience
• Substantial past regulatory experiences, including interactions with FDA, EMA, and PMDA and BLA/NDA/MAA submission experiences
• Strong knowledge of relevant guidelines for regulatory activities (e.g. ICH E3, ICH E8, ICH E9 (R1), ICH E10)
• Broad and thorough understanding of statistical principles and clinical trial methodology (e.g. estimands, missing data, blinded sample size-reassessment, non-randomized trials, bio-equivalance trials)
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• Extensive knowledge in the development of clinical development plans (CDPs) including Biomarker, PK, PK/ PD and efficacy/ safety studies
• Strong knowledge of programming in SAS and/ or R
• Excellent knowledge of CDISC standards, such as SDTM, ADaM and define.xml
• Strong verbal and written communication skills. Ability to explain methodology and consequences of decisions in lay terms
• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership
• Strong people manager with track record of staff development