Associate Director, Programming
ClinChoice
full-time
Posted on:
Location: Massachusetts • 🇺🇸 United States
Visit company websiteJob 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)