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Associate Director, Statistical Programming, Early Development

Sarepta Therapeutics, Inc.

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Cambridge, MA
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Job Description

As posted by the hiring company

Job Overview:

Reporting to the Head of Statistical Programming, the individual will be responsible for providing hands-on programming support and technical guidance on early development projects which includes clinical pharmacology studies, genomics data support, and non-clinical studies. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit non-clinical and clinical data for individual studies. This individual will work closely with Clinical Pharmacology and Genomics teams on data requests for various exploratory data analysis and visualizations.

Primary Responsibilities Include:

  • Collaborate with Clinical Pharmacology and Genomics team members to develop Data and QC processes for data requests.
  • Improve the efficiency and quality of existing workflows for the provision of data sets and scientific contributions for the Clinical Pharmacology and Genomics projects.
  • Perform exploratory data analyses and visualizations in interaction with the Clinical Pharmacology or Genomics teams.
  • Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned early development projects.
  • Familiar with statistical analysis methods and clinical data management concepts.
  • Produce and deliver CDISC and regulatory compliant SDTM, ADaM, and SEND standard datasets.
  • Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high quality fashion, consistently meeting objectives of the study, and regulatory requirements.
  • Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and SEND datasets, fit-for-purpose analysis datasets, and TFLs.
  • Review or author SDTM, ADaM and SEND datasets specifications for datasets programming.
  • Provide programming support for adhoc analysis.
  • Manage project timelines and schedules of specific phases of projects with internal personnel and external vendors.
  • Provide oversight of statistical programming activities of vendors.
  • Participate in the development and review of Statistical Programming SOPs.
  • Train or mentor junior statistical programming staff.

Desired Education and Skills:

  • MS in statistics, computer science or a related field with at least 8 years (or BS in statistics, computer science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry.
  • Prior experience of independently leading projects for regulatory submission for statistical programming activities.
  • Prior experience working on non-clinical and PK/PD studies.
  • Proven ability to manage CRO relationships and oversee programmed deliverables.
  • Experience in providing statistical programming support to non-clinical and early and late phase clinical trials, and regulatory submissions (NDA, MAA).
  • Proficient in SAS programming.
  • Experience with R a plus.
  • Knowledge of CDISC standards for SDTM, ADaM, and SEND and FDA electronic data submission requirements.
  • Experience in developing programming specifications, electronic submission data package in the eCTD format.
  • Experience with FDA and ICH regulations and guidelines.
  • Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
  • Prior experience working with controlled statistical computing environment for supporting the analytical needs of statistical programming and biostatistics.
  • Excellent written and verbal communication skills and organizational and documentation skills.
  • Ability to work on a multidisciplinary team that may include Biostatistics, Data Management, Clinical Pharmacology, Genomics, Medical Writing, Pharmacovigilance, Clinical Operations, Quality Assurance, IT, etc.
  • Demonstrated positive attitude and the ability to work well with others.
  • 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.