Director, Safety and Monitoring Biostatistics

4 days ago

King of Prussia, 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 Director, Safety and Monitoring Biostatistics? This is a hybrid role located in our King of Prussia PA, Marburg Germany, Bern Switzerland, Zurich Switzerland or Geneva Switzerland office. You will report to the Head, Statistical Innovation.

You will ensure that appropriate statistical methods are used to address safety concerns and that modern statistical monitoring methods are used for both safety and quality throughout the clinical development lifecycle across the portfolio.

Responsibilities:

  • You will minimize the risk of unforeseen safety issues for the company by ensuring the use of proper statistical methodology for safety analyses within studies across the CSL portfolio, to include aggregate safety analyses, early risk management plan, blinded and unblinded safety monitoring (through internal safety review committees or IDMC)
  • Stay up to date with developing methodologies related to safety analysis and signal detection, including identifying adverse drug reactions per regulatory guidance
  • Position CSL as an industry leader in safety statistics by developing innovative methodologies to incorporate accumulating knowledge on safety risks during clinical development, to effectively validate or discharge potential safety concerns
  • Collaborate with Safety and Pharmacovigilance in developing processes and practices to support safety assessment and Go/NoGo decision making. Reach out to diverse stakeholders to better understand potential issues and best practices, providing leadership in matrix environment
  • Work with CDIS and Statistical programming to ensure the data integration processes and tools support safety analyses during development, regulatory submissions, and in preparations for future analyses of aggregate safety data

  • Support non-clinical safety analyses to include donor safety, lot decisions, or other questions on an adhoc basis

  • Support analysis and interpretation of safety data for contributions to Health Authorities across studies

Qualifications:

  • MS in Biostatistics, Statistics, or related fields
  • 10+ years in Clinical Development in a Pharmaceutical or Biotechnology setting
  • Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
  • Experience in interactions with major regulatory authorities and regulatory submissions Demonstrated statistical expertise in facilitating clinical development strategy
  • Demonstrated statistical expertise in facilitating clinical development strategy
  • Expertise in CDISC, statistical programming, and/or data standards and Biostatistics and Statistical Programming Operations

.BENEFITS

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

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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