Role Summary
An East-Coast clinical-stage Biopharma is looking for an experienced Statistical Programmer to support early development studies, including PK/PD and modeling work.
Responsibilities:
- Deliver hands-on statistical programming across early-phase clinical studies.
- Develop and validate SDTM and ADaM datasets, along with associated TLFs, with a strong focus on PK/PD outputs.
- Work closely with cross-functional teams to support exploratory analyses and early efficacy signals.
- Contribute to submission-ready documentation, including eCRTs and programming specifications.
- Tackle complex data handling tasks and ad hoc reporting using raw clinical datasets.
- QC outputs and ensure programming deliverables meet high quality and regulatory standards.
Requirements:
- Degree in a relevant field such as Computer Science, Statistics, or Life Sciences.
- Strong experience in statistical programming for early-phase clinical trials, including PK/PD data.
- Proficiency in SAS; knowledge of R a plus.
- Previous experience working with SDTMs, ADaMs, and TLFs for exploratory and modeling purposes.
- Comfortable operating in a hands-on capacity within a sponsor environment.
- Excellent problem-solving skills and the ability to adapt in a fast-moving development setting.
Rate dependent on experience and engagement type: $65 - $85 per hour