Principal Statistical Programmer

This is what you will do:

The Principal Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and ADaM specifications, as well Tables, Listings, and Figures (“TLFs”) for analysis of efficacy data.  He/she will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. He/she will serve as a Programming Lead and represent Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams.  The Principal Statistical Programmer will act as a mentor to all other Statistical Programmers. He/she must demonstrate, at a minimum, an expert ability to comprehensively integrate statistical concepts with SAS Programming in the most efficient and effective manner.  

You will be responsible for:

• Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. 

• Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. 

• Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs based on Protocol SAP. 

• Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. 

• Supervise/manage external vendors and contract programmers. 

• Oversee progress of programming activities.

• Review, maintain, and approve protocol specific documents as necessary.

• Provide guidance and mentoring to peer and junior-level Programmers. 

• Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies. 

• Contribute ideas and thoughts towards the optimization of standard operating procedures. 

• Lead team meetings when appropriate.

• Any other activities as required. 

You will need to have:

• Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics or another related discipline

• Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. 

• Proven ability to:

• Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. 

• Independently and collaboratively resolve problems

• Clearly communicate processes and standards with management and team members

• Expertise in using SAS/Base, SAS/Macro, SAS/STAT. 

• Knowledge of SAS/Graph, and SAS/SQL  

• Knowledge of:

• SDTM and ADaM

• Relational Databases.

• Good Clinical Practices. 

• Good Programming Practices. 

• 21CFR Part 11 Standards. 

• Integrated Summary Safety/Efficacy Analyses. 

• Safety data and Coding Dictionaries (MedDRA and WHODD).

• ICH eCTD format.