Principal Statistical Programmer

Employer
CSL Behring
Location
Cambridge, Massachusetts
Posted
Feb 24, 2021
Ref
R-130733
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Principal Statistical Programmer is 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.

Responsibilities include:
  • Manage assignments and statistical programming on single or multiple projects. Assist with statistical quality assurance review.
  • Direct the work of statistical programming services provided by vendors to achieve quality, timely, and cost-effective study deliverables. Assist with statistical quality assurance review. Review and QC deliverables from ESP
  • Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
  • Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies. Develop standard macros and/or tools in the chosen 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, Experience Competencies:
  • At least 6 years of experiences in Clinical Development in a Pharmaceutical or Biotechnology setting
  • Experience leading statistical programming projects in the pharmaceutical industry demonstrated by the ability to independently act as the point of contact on the statistical programming for all phases of clinical trials, directing the work of one or more programmers.
  • Expert in SAS language procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH;
  • Subject matter expert in CDISC standard implementation and electric submission
  • Exhibit project management skills as related to statistical programming including teamwork, planning, organization, delegation, coordination, metrics, and oversight of contractors;
  • Proficient in medical terminology and clinical trial methodologies.
  • Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs integrating quantitative sciences, strong drug development knowledge