Principal, Statistical Programmer​

Job Description

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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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!