CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Director Statistical Programming Lead ? The job is in our King of Prussia, PA, Waltham MA or Zurich Switxerland office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director Programming.
You will provide leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporing, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas.
You will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards.
Main Responsibilities:
Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high quality, timely, delivery. Ensure realistic resource planning.
Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis.
Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other adhoc requests.
Manages, hires, and mentors direct reports including annual evaluations and goal setting.
As a member of the programming leadership team within biometrics, creates, maintains ensures compliance with programming process and strategy to facilitate accurate and timely analysis programming.
Help bring state of the art programming methods and tools to the organization and drive automation of delivery, including AI.
Qualifications and Experience Requirements:
BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
At least 15 years of experience in the biotech, pharma, or CRO industries
Preferred 5 or more years of direct supervisory experience
Experience with CRO management and/or CRO work experience
Extensive understanding of clinical programming and/or statistical programming processes and standards
Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros, preferred managing team performing these activities as well
Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
#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 biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
