Serves as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead

Primary Responsibilities Include:

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
• Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets
• Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
• Provides input in the design and development of case report forms and clinical databases
• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs
• Programs quality checks for clinical study raw data and report the findings to Data Management
• Provides input in the design and development of case report forms and clinical study databases
• Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming
• Provides programming support for adhoc analysis
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
• Manages timelines and schedules of specific phases of projects with internal personnel and external vendors
• Acts as lead programmer for a study
• Reviews or validates statistical deliverables of vendors for assigned project(s)

Desired Education and Skills:

• MS in 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.
• Experience in providing statistical programming support to early and late phase clinical trials.
• Excellent skills in SAS programming and statistical reporting.
• Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
• Familiarity with FDA and ICH regulations and guidelines.
• Excellent problem-solving skills.
• Good written and verbal communication skills and organizational and documentation skills.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
• Ability to prioritize and multi-task effectively
• Demonstrated positive attitude and the ability to work well with others.

LI-Remote

This position is remote. However, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $100,000 - $125,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
• Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets
• Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
• Provides input in the design and development of case report forms and clinical databases
• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs
• Programs quality checks for clinical study raw data and report the findings to Data Management
• Provides input in the design and development of case report forms and clinical study databases
• Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming
• Provides programming support for adhoc analysis
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
• Manages timelines and schedules of specific phases of projects with internal personnel and external vendors
• Acts as lead programmer for a study
• Reviews or validates statistical deliverables of vendors for assigned project(s