Associate Director, Statistical Programming, Early Development

Company: Sarepta Therapeutics
Location: Cambridge
Posted on: September 20, 2022

Job Description:

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.

Keywords: Sarepta Therapeutics, Cambridge , Associate Director, Statistical Programming, Early Development, Executive , Cambridge, Massachusetts