Principal, Scientific Statistical Programming

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 Principal, Statistical Programmer? The job is in our King of Prussia, PA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week.

You will be a member of the Biostatistics team and plays a lead role in performing all statistical programming tasks required for clinical trial analysis and reporting. This position works closely with other
members of the BDPM on various clinical projects. During clinical trial from start up to the end of the clinical data analysis/report, the incumbent will be responsible for planning, preparing, managing, coordinating and performing
programming activities Is accountable oversee that applicable SEQ SOP and standards are implemented. Provide technical expertise for regulatory submission relevant to statistical programming deliverables. Support the function
director on managing and facilitating timelines and resource for the statistical programming group. This role has global responsibilities with potential for matrix management, and participation in global teams.

Main Responsibilities:

1. Provide statistical programming expertise in statistical programming
deliverables, including data processing, CDISC compliance, regulatory
submission and SAS coding.

2. Help function director manage resources, timelines, and assignments for a
single or multiple clinical trials assigned to him/her. Estimate resource
needs. Work closely with the function director on resource allocation,
timeline consolidation and implementation.

3. Oversee the work of statistical programming services provided by vendors to
achieve quality, timely, and cost-effective study deliverables. Act as the
primary point of contact on all statistical programming matters with external
vendors that provide statistical programming services to Seqirus.

4. Mentor junior programmers for their statistical programming activities.
Provide technical support and mentoring to junior programmers.

5. Support development and maintenance of the Seqirus statistical
programming relevant standards, SOPs/WI and guidance.

6. Perform statistical programming on various tasks for clinical data analysis
needs, including but not limited to generating Study Data Standardization
Plan (SDSP), SDTM data/ADaM data specifications, CRF annotation for
SDTM, define.xml, reviewers guide, system and study level macros, tables,
listings and figures, regulatory e-submission components.

7. As a SME, establish and implement programming standards and comply with
regulatory requirements among project team members and across all
studies. Develop standard macros and/or tools for the statistical
programming platform for data analysis and reporting. Ensure that statistical
programs developed for specific protocols are effectively portable to other
protocols (Reusable code).

Qualifications and Experience Requirements:

Bachelor's Degree life science, computer programming, statistics etc.
5+ years of experience in scientific programming/simulations
Expertise in R or Python, and knowledge of SAS
Knowledge of GIT, or similar version control system
Experience in working with larger data sets (>1m records)
Ability to understand statistical issues, extract specifications, and convert into working simulation code

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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…