Principal Statistician, Biostatistics

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jul 09, 2021
Ref
R-139345
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time

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 Purpose:

The Principal Biostatistician leads components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables.

Job Responsibilities:

1. Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.

2. Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.

3. Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.

4. Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)

5. Be responsible for interpreting analysis results and ensuring reporting accuracy.

6. Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.

7. Be accountable for the TFL/CDISC package for study report and regulatory submission.

8. Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations

9. Support or lead improvement initiatives within the department, organization and/or pharma industry

Reports To:

Director, Biostatistics, Therapeutic Area Lead

Direct Reports:

None

Job Specifications:

Education

  • PhD or MS in Biostatistics, Statistics or related field

Experience

  • PhD with 5 years of experience or MS with 8 years of experience in drug development
  • Experience providing statistical leadership at a study level
  • Demonstrated statistical contribution in facilitating and optimizing clinical development
  • Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
  • Experience supporting regulatory interactions or submissions preferred

Competencies

  • Broad knowledge of clinical development and processes
  • Ability to collaboratively work and provide leadership in matrix environment
  • Strong interpersonal and communication skills (verbal and written in English)
  • Good working knowledge of SAS and/or R
  • Track record of innovation or expertise in statistical methodologies in the context of clinical development desired
  • Familiarity with relevant regulatory guidance documents
  • Expertise in
    • CDISC, statistical programming, and/or data standards
    • Biostatistics and Statistical Programming Operations