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 + 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
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