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Associate Director Medical Affairs Biostatistics

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Start date
Nov 22, 2022

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Job Details

Job Description

The Associate Director, Medical Affairs Biostatistics will support product launch and life-cycle management of marketed products by generation of scientifically valid information from clinical trials and/or real-world data. The successful incumbent will be a member of cross-functional teams and contribute to the strategic and operational decisions for one or multiple therapeutical areas (TAs). He/she will provide statistical support to Medical Affairs, Market Access, Health Economic Outcome Research (HEOR) within CSL Behring.

Responsibilities:
• Effectively engages as a matrix team member on projects as a strategic partner in the evidence generation and publication strategy
• Advising, planning and execution of exploratory analyses of clinical trial data for publication, Health Technology Assessment (HTA) evaluation and payer negotiation
• Participation in CRO governance; Manage outsourcing operations or work with internal statistical programmers within the responsible projects
• Closely collaborate with key stakeholders for the design and analysis of registry trials and RWE (Real World Evidence) studies initiated by Medical Affairs, Market Access, and HEOR. Evaluate statistical validity of proposals of those studies and advise on reasonable improvements to ensure the highest quality of published evidence
• Takes accountability for ensuring timely and high-quality statistical deliverables
• Be responsible for interpreting analysis results and ensuring reporting accuracy

• Develop, assess, and conduct training in basic statistical methods and topics as needed

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


Qualifications:
• A graduate degree in Statistics, Epidemiology, Data Science or related field is required, Ph.D. preferred.
• At least 6 years (for MS 9 years) of experience in Medical Affairs or other market facing organizations
• Broad understanding and application of innovative statistical methods for exploratory analyses of clinical data and generating real-world evidence, including causal inference methods for analyzing non-randomized data
• Knowledge of clinical data and real-world data source (e.g., healthcare administrative data, electronic health records, disease/patient registries, etc.)

• Experience with HTA methods and Payer facing analytics, such as economic modeling and indirect treatment comparisons

Competence:

• Ability to collaboratively work and provide leadership in matrix environment

• Ability to be flexible and adapt quickly to the changing needs of the organization

• Comfortable around M.D.s, both internal and external to the company

• Strong interpersonal and communication skills (verbal and written in English)

• A solutions-oriented and self-motivated mindset

• Hands-on programming skills in SAS and/or R.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
US
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