Sr. Statistical Programmer

– Onsite Preferred – San Diego; will consider remote for an ideal candidate
– 12 month renewable contract

Responsibilities will include, but are not limited to, the following:
•    Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
•    Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
•    Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
•    Perform programming validation to ensure the quality of analysis datasets and programming outputs.
•    Ensure consistency and adherence to standards within the project.
•    Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
•    Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.
•    Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
•    Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
•    Serve as the lead programmer in support of NDAs, sNDAs.
•    Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables. 
•    Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
•    Contribute to the creation, maintenance, and validation of standards for outputs and macros.
•    Provide training on SOPs, WPs and standard programs.
•    Contribute to the creation of naming conventions and development of the programming environment.
•    Oversee the services provided by CROs.
Skills/Knowledge Required:
•    Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s Degree is preferred.
•    7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.
•    Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
•    Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
•    Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
•    Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. 
•    Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. 
•    In-depth understanding of regulatory, industry, and technology standards and requirements.  
•    Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. 
•    Demonstrated ability to work in a team environment with clinical team members.
•    Good planning and project management skills.  
•    Good interpersonal, communication, writing and organizational skills.