Associate Director, Observational Research Excellence

1 month ago

King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time

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, Observational Research Excellence ? The job is located in the King of Prussia PA or Waltham MA. This is a hybrid position. You will report to the Director, Medical Affairs Biostatistics.

Responsibilities:

You will be a subject matter expert on RWD and initiate tasks to build internal RWD related services. This includes: creating a searchable catalog of available in-house RWD, evaluating commonly used or new RWD datasets in therapeutic areas of focus for CSL, making up-to-date information accessible and available to all CSL partners. If needed, you will also lead the efforts to archive the RWD generated/owned by CSL.

Independently build RWD analysis using multiple analytical tools, and assist other team members/collaborators with analyses.

Support partners in protocol development of data sources, execution of protocol-defined analysis, and interpretation and presentation of results for designated non-interventional studies using RWD.

Manage operational and logistic aspects of projects of FORExecellence and provide regular updates to FORExecellence leaders and beyond. This includes: tracking and recording progress of FORExcellence tasks, leading educational and awareness events, and enterprise communications.

You will assess information environment, available RWD, methodological and analytical tools to ensure current needs are met for RWE generation and such future needs are communicated for assessment by evidence generation teams of different functions.

Qualifications

  • Master's degree in these disciplines epidemiology, statistics, biostatistics or related quantitative discipline
  • 7 years of post-graduate experience in the pharmaceutical/biotech industry, regulatory, academia, or Contract Research Organizations with a pharmaceutical/biotech company customer base.
  • At least 3 years hands-on experience in real-world evidence analytics including writing/reviewing/validating programs in SAS, R, or SQL is required; experience and/or knowledge of Python programming is a plus.
  • Broad and in-depth hands-on professional experience of RWD such as administrative claims (e.g., IBM® MarketScan® Research Databases), EHR/EMR (e.g., Optum EMR, UK CPRD, UK HES), disease registries (e.g., INCBASE), integrated claims/EMR (e.g., Optum Market Clarity) and public-use databases (e.g., NHANES). Experience of both US and ex-US RWD
  • Experience identifying research cohort of interest using disease, procedure, therapeutic classification codes such as ICD-9-CM, ICD-10-CM, SNOMED, LOINC, NDC, HCPCS, CPT, etc., is required.

BENEFITS

  • Medical, Dental Vision
  • 401K
  • Paid time Off

#LI-Hybrid

Our Benefits

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.

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

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