Principal Statistical Programmer

Job Title

Responsibilities:

Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.

Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.

Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts and other clinical publications; support systems to produce electronic regulatory submissions.

Assist in establishing standardized programming procedures and work instructions.

Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities.

Develop and maintain clinical processing workflow systems.

Assist in the development of client proposal documents.

Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.

Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.

Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.

Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.)

Records handling (e.g., Chapter 21 of the US Code of Federal Regulation – Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards)

Assist in updating/writing standard operating procedures (SOPs)

Develop tools in SAS® for data analysis and reporting that comply with regulatory requirements.

Develop specifications (e.g., metadata files), annotate CRFs and create SAS® programs for the mapping of raw datasets to CDISC SDTM standards.

Create define.xml files from metadata files for SDTM and ADaM

Convert data received in other formats to SAS® datasets.

Requirements:

Must have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS

Knowledge of SDTM, ADaM, FDA and ICH guidance

Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems.

Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.

Consistent experience as a lead statistical programmer on several concurrent projects

Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions

Strong mentoring skills as shown by leadership of projects and if applicable, junior team members.

Excellent analytical skills

Proven ability to learn new systems and function in an evolving technical environment.

Ability to negotiate and influence to achieve results.

Good presentation skills

Good business awareness/business development skills (including financial awareness)

Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.

Work effectively in a quality-focused environment.

Knowledge of other programming languages and database management software packages is a plus.