CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels 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 Senior Statistical Programmer? The job is in our King of Prussia, PA office. This is a hybrid position and is onsite three days a week. You will report to the Director, Statistical Programming.
You are responsible for providing hands-on support and technical guidance on clinical study teams. The development of study and ad hoc output including, but not limited to: ADaM datasets, tables, figures and listings output and/or QC of requested output is the main focus of this role. This individual, working closely with the study statistician will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures and listings and submission packages. This individual will participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. This individual will interface with other departments (eg, Biostatistics, Data
Management, Regulatory Operations, Medical Writing, ESP teams) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. You will participate in department and cross functional technology development and process improvement initiatives.
Main Responsibilities:
1. Collaborates with the study statistician to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Leads the production and validation efforts for the designed output, this may include oversight of work by CROs.
2 Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml). Supports the review of related deliverables when provided by CROs.
3 Leads requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data.
4 Leads the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
5. Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
Qualifications:
• BSc in Computer Science, Mathematics, Statistics or related area with relevant
experience
• At least 5 years of experience in either clinical programming and/or statistical
programming, within the CRO/pharmaceutical environment using SAS
Software.
• Understanding of clinical programming and/or statistical programming
processes and standards.
• Experiences with statistical programming using the SAS software including
development and use of SAS Macros.
• Knowledge in CDISC standards (CDASH, SDTM, ADaM).
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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 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.
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.