ClinChoice

Associate Director, Programming

ClinChoice

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

Visit company website
✨ AI Apply
Manual Apply

Job Level

Senior

About the role

  • Lead and oversee statistical programming activities to support clinical trial projects
  • Manage programmers and CROs and provide statistical programming oversight to vendors
  • Review and validate datasets and TFLs programmed by vendors
  • Support building programming processes for clinical studies and regulatory submissions
  • Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver timely, high-quality data deliverables
  • Develop and implement data review/reporting tools and other statistical applications as appropriate
  • Review study documents (SAP, DMP, CRF, annotated CRF, TFL specifications) and provide expert feedback
  • Build, mentor and manage a team of programmers to support clinical trials and pipelines
  • Generate ad hoc analyses on an ongoing basis

Requirements

  • Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
  • A minimum of 10 years’ progressive clinical trial programming experience in biotech/pharma industry
  • Advanced SAS programming skills and experience in other statistical software (e.g., R)
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
  • Phase 3 and BLA submissions experience preferred
  • Excellent organizational skills and ability to prioritize tasks
  • Excellent communication and interpersonal skills
  • Experience managing CROs and other data vendors
  • Strong leader with a growth mindset and ability to promote a psychologically safe environment
  • Ability to keep pace in a fast-moving organization
  • Advanced knowledge of state-of-art statistical programming methods in clinical study setting
  • Knowledge of ICH guidelines and FDA/EMA/other regulatory authority guidance
  • Experience working in a remote virtual environment
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Ability and willingness to travel per business needs (at least 4 – 8 times per year)