Principal Statistical Programmer

Position Summary:
Support, lead, and provide oversight to SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet project needs; Provide technical expertise to the development of programming standards and procedures. May serve as the project manager for assigned projects.

Essential functions of the job include but are not limited to:

• Review CRFs, edit check specifications and table mock-ups
• Create specifications for SDTM and ADaM datasets
• Oversee generation of blankcrf.pdf aCRFs and define.xml files
• Generate SDTM and ADaM datasets, tables, listings, and figures to support the analysis of clinical trials data
• Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Perform quality control (including documentation) for SAS programs and other study documents (e.g., presentations and reports)
• Review, maintain and approve study documents per standard procedures
• Interact with clients and lead statistical programming efforts for the project team; serve as the primary project team representative, delegating work as appropriate
• Prepare reports (i.e. patient profiles, SAP related outputs, interim analysis) for Data Monitoring Committees (DMCs)
• Assist with training of new hires; provide ongoing training and mentorship for statistical programmers
• Participate Lead or oversee in the development and maintenance of departmental procedures/standards
• Program, test and document global utility programs and tools in accordance with standards and validation procedures
• Provide technical oversight and leadership when needed for analysis and reporting; may serve as the project manager for assigned projects
• Lead cross-functional development activities
• Other duties as assigned

Qualifications:

Minimum Required:
Bachelor's degree in Statistics, Mathematics, Computer Science, or in a related field; 8+ years SAS programming experience (preferably in Biotech / clinical trials / related industry)

Other Required:

• Knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11 and FDA guidelines
• Broad programming experience supporting clinical trials in the Biotechnology / Pharmaceutical / CRO Industry

Preferred:

• SAS Certified Advanced Programmer for SAS 9 or equivalent proficiency
• Broad experience with Oncology and Rare Diseases
• Broad experience with ISS/ISE programming and submissions

Skills:

• Excellent organizational skills, time management, and the ability to coordinate workload to meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others (both internally and externally to foster client relationships)
• Excellent problem solving skills
• Ability to program/QC more complex analysis datasets and outputs (i.e. tables, ADaMs, efficacy related outputs, figures) in an efficient and readable manner
• Proficient in SAS macro programming
• Advanced computer skills
• Demonstrated proficiency in interpreting statistical analysis plans

Competencies:

• Sound judgment/decision making
• Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients
• Service oriented, accountable and flexible
• Keen attention to detail in reviewing outputs for project deliverables
• Ability to fulfill a variety of data-related roles while building company strength and experience in data activities
• Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures