Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a global biotechnology company on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

Reporting into the Lead RWE Programmer, Statistical Programming the Senior Real-World Data Analyst will be responsible for providing hands-on support and technical guidance on project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze real-world data (e.g., claims data, Patient Reported Outcomes, real-world observational studies). This individual will participate in departmental and cross functional technology development and process improvement initiatives.

Primary Responsibilities Include

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned projects(s).
• Create and validate tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
• Provide input in the user requirements specification, system design specifications, validation plan, and installation/operational/performance qualification for statistical programming systems.
• Create automated, standard programming; SAS macros, SQL coding in relational databases (e.g. Snowflake).
• Accurately and efficiently work with Real-World Evidence (RWE) study leads to conduct studies from protocol to output generation following quality standards.
• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
• Provides programming support for ad hoc analysis.
• Manages project timelines and schedules of specific phases of projects with internal personnel and external vendors.
• Provide oversight of statistical programming activities of vendors.

Desired Education And Skills

• MS in biostatistics/statistics, computer science or a related field with at least 3 years (or BS in statistics, computer science or a related field with at least 5 years) of SAS programming experience in healthcare data analysis, pharmaceutical, or biotech industry.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, RWE leads, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
• Demonstrated ability and experience in the analysis and reporting of real-world studies (retrospective and prospective), Patient Reported Outcomes.
• Experience conducting analysis in retrospective claims data (open and closed claims) including ICD-10/J-code, HCPCS coding (survey data, patient-reported and clinical trial data a plus).
• Experience in project management of statistical programming activities.
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Familiarity with GPP, GCP, FDA and ICH regulations and guidelines.
• Excellent skills in SAS programming and statistical reporting. R, Python programming skills are a plus.
• Experience using SQL and management of large data.
• Understand appropriate QC steps in handling large data including data merging.
• Excellent written and verbal communication skills and organizational and documentation skills.
• Excellent problem-solving skills.
• Ability to prioritize and multi-task effectively.
• Demonstrated positive attitude and the ability to work well with others.