Associate Director Medical Affairs Biostatistics

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor. 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.

Could you be our next Associate Director, Medical Affairs Biostatistics. The job is located in the King of Prussia office. This is a hybrid position. You will report to the Director, Medical Affairs Biostatistics

You will support product launch of pipeline assets and life-cycle management of marketed products by generation of scientifically valid information from clinical trials and real-world data. You will be a member of the team and contribute to the strategic and operational decisions for one or multiple therapeutic area (TAs). You will provide statistical support to Medical Affairs, Market Access, Health Economic Outcome Research (HEOR) within CSL Behring.

Responsibilities:

• Engage as a matrix team member on projects as a strategic partner in the evidence generation and publication strategy

• Advise and plan 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

• Collaborate with partners for the design and analysis of registry trials and RWE (Real-world) 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

• Take accountability for ensuring and high-quality statistical deliverables

• Interpret analysis results and ensuring reporting accuracy

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

• Lead improvement programs within the organization, such as creation/revision of statistical analysis plan (SAP) templates.

Qualifications:

• A graduate degree in Statistics, Biostatics, or related field is required

• 6+ years of experience supporting Medical Affairs, Market Access or other commercial facing organizations in pharmaceutical or biotech industry.

• Broad understanding and application of statistical methods for exploratory analyses of clinical data and generating real-world evidence, including causal inference methods for analyzing non-randomized data.

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

• Knowledge of clinical data and real-world data source (e.g., healthcare administrative data, electronic health records, disease/patient registries)

BENEFITS

• Medical, Dental Vision

• 401K

• Paid time Off

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CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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.

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