Principal, Scientific Statistical Programming

Principal, Scientific Statistical Programming page is loaded## Principal, Scientific Statistical Programming locations:
Americas, US-PA, King of Prussia, CSL Behring:
EMEA, CH, Glattbrugg, CSL Behring:
Americas, US-MA, Waltham, CSL Behring time type:
Full time posted on:
Offerta pubblicata oggijob requisition :
R-269604

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.

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.
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* 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#LI-HYBRID##
** 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…