Principal, Scientific Statistical Programming

CSL Plasma • Waltham, MA

3d • Hybrid

About The Position

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.

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

Responsibilities

• Provide statistical programming expertise in statistical programming deliverables, including data processing, CDISC compliance, regulatory submission and SAS coding.
• 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.
• 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.
• Mentor junior programmers for their statistical programming activities. Provide technical support and mentoring to junior programmers.
• Support development and maintenance of the Seqirus statistical programming relevant standards, SOPs/WI and guidance.
• 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.
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees