Principal Statistician, Biostatistics

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jan 26, 2021
Ref
R-129315
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Overview

This is an opportunity to work within Quantitative Clinical Sciences and Reporting (QCSR), a group of scientists devoted to plan, execute, and interpret clinical data, studies, RWE, and contribute the quantitative aspect to corporate decision making. You will have opportunities to closely interact with colleagues from Biostatistics, Medical Writing, Epidemiology, Statistical Programming, Medical Affairs Support, and Patient-centric endpoint development. The group was formed to leverage synergies and promote the exploration and implementation of advanced analytical methods based on Artificial Intelligence.

As part of the Biostatistics group within QCSR, you will contribute and build our capabilities in biostatistics both technically and operationally. Technically, you will have the opportunity to participate as we expand into new areas, such as artificial intelligence and machine learning, real world evidence and causality, applications of Bayesian statistics, advanced Adaptive Design, etc. Operationally, you can contribute to process improvement, organizational structure, automation of analysis, and other activities in addition to providing statistical leadership to the activities in your purview. You will play a key role in regulatory strategy and interactions. All of this is in an environment that is focused on personal development, teamwork, and mutual support.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Principal Biostatistician at CSL Behring will be working with the team dedicated to providing innovative therapies to enhance patients' lives with Respiratory diseases. The successful candidate will work in the clinical matrix team as a strategic, collaborative drug developer by providing statistical expertise to products at multiple phases to address unmet needs in the Respiratory therapeutic area.

Responsibilities
  • Apply statistical expertise to study design and contribute to protocol development
  • Provide for project-wide planning of analyses; accountable for quality and timely delivery of interim and final results, and ad-hoc analyses
  • Collaborate with, direct and monitor work of internal statistical programmers, study statisticians and/or CRO statistical teams under supervision.
  • Support Biostatistics interactions with authorities
  • Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculationsSupport or lead improvement initiatives within the department, organization and/or pharma industry

Competencies:
  • Advanced knowledge and training in applications of statistical methodologies
  • Ability to collaboratively work in matrix environment and provide leadership in matrix environment
  • Strong interpersonal and communication skills (verbal and written in English)
  • Good working knowledge of SAS and/or R
  • Experience with CROs (either managing a CRO, or having worked in a CRO)

Qualifications
  • Education: M.S. or PhD in Statistics or related field.
  • Experience: PhD with 5 years of experience or M.S. with 8 years of experience in drug development