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Associate Director, Biostatistics

Biogen
Raleigh, NC
  • Posted: February 01, 2023
  • Full-Time
Company Description

At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we're changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients' lives and on changing the course of medicine.

Job Description

About this role

As the Associate Director of Biostatistics, you are responsible for leading complex or integrated study design and data analysis in clinical development, biomarker development, research, Biotherapeutic and Medicinal Sciences (BTMS) or Pharma Ops & Technology (PO&T). You act as Research and Development Project Team (RDPT) Biostatistician, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports and regulatory documents with high quality. You build and maintain strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework. You provide responses to statistical issues arising in regulatory, other legal settings, or external development partners. You provide mentorship to new/junior biostatisticians, and you also contribute to the long-term growth strategy of the department by participating in process improvement initiatives and keeping up to date of and contributes to the current statistical methodology development.

What you'll do
  • Key player in the strategic planning and execution of the clinical development plan for the assigned project; provide strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including Investigational New Drugs (INDs), Biologic License Applications (BLAs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
  • Manage assigned staff and Functional Service Provider (FSPs) statisticians to ensure quality and consistency of the deliverables; provide guidance and support to facilitate their development and enhanced efficiency; provide regular feedback to staff and Analytical and Data Science (ADS) management
  • Provide key strategic contributions in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with Key Opinion Leaders (KOLs) as required.
  • Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, Clinical Study Reports (CSRs), regulatory documents, and manuscripts), and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
  • Participate in approved process improvement initiatives; keeps up to date on current statistical methodology development and regulatory environment

Who you are:

You are an Associate Director with statistical expertise and have experience in managing the activities of clinical programs. You can develop innovative/creative statistical/technical solutions to complex problems and have strong verbal and written communication skills.

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Qualifications

Required Skills:
  • PhD in Biostatistics/Statistics or equivalent with a minimum of 6-7 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 8-9 years relevant experience
  • Substantial past regulatory interactions.
  • Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
  • Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
  • Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
  • Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership


Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.

Videos To Watch
https://www.youtube.com/watch?v=S8n1OGEJWr0
https://youtu.be/L4fEAaf4caQ

Biogen

Address

Raleigh, NC
27601 USA

Industry

Healthcare

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