Contract Biostatistician (60-hour project — SAP & final analysis)
- Posted 1 month ago
- Remote
Job description
Profound Health Institute is running a fully remote, 400-participant, 8-week, randomized, double-blind trial of Profound Care, a voice-based AI therapy for Major Depressive Disorder. We need a freelance biostatistician to own the statistical work from protocol finalization through database lock.What you’ll do
• Draft and sign the Statistical Analysis Plan, create a stratified block-randomization list, and review case-report forms (about 20 hours, due ten business days after contract start).
• Perform a blinded sample-size re-estimation mid-enrollment and issue a memo (about 5 hours).
• After last-patient-out, clean and lock analytic datasets, run all primary, secondary, and sensitivity analyses in R or SAS, and produce publication-ready tables, listings, and figures for the Clinical Study Report (about 35 hours, due three weeks after database lock).What we’re looking for
• MS or PhD in Biostatistics or Applied Statistics.
• At least two FDA-regulated device or drug trials where you authored the SAP.
• Solid mixed-model / repeated-measures experience with clinician-rated scales such as MADRS or CGI.
• Fluency in R (tidyverse, lme4) or SAS (PROC MIXED, GLIMMIX) and reproducible code habits.
• Ability to start no later than 19 Aug 2025 and deliver a draft SAP within five business days.Terms
Hourly 1099 contract. Estimated 60 billable hours; any overage requires pre-approval. Invoices net 15 via ACH. Work is 100 % remote; you’ll have access to a secure GitHub repo and validated EDC.How to apply (by 14 Aug 2025)
Email ******with your two-page CV, a redacted excerpt from a recent SAP or CSR you authored, confirmation you can meet the timelines above, and your hourly rate expectation. Short-listed candidates will have a brief Zoom interview and code-review screen.Help us bring the first prescription voice-AI therapy for depression to patients—your stats expertise will make it possible.
• Draft and sign the Statistical Analysis Plan, create a stratified block-randomization list, and review case-report forms (about 20 hours, due ten business days after contract start).
• Perform a blinded sample-size re-estimation mid-enrollment and issue a memo (about 5 hours).
• After last-patient-out, clean and lock analytic datasets, run all primary, secondary, and sensitivity analyses in R or SAS, and produce publication-ready tables, listings, and figures for the Clinical Study Report (about 35 hours, due three weeks after database lock).What we’re looking for
• MS or PhD in Biostatistics or Applied Statistics.
• At least two FDA-regulated device or drug trials where you authored the SAP.
• Solid mixed-model / repeated-measures experience with clinician-rated scales such as MADRS or CGI.
• Fluency in R (tidyverse, lme4) or SAS (PROC MIXED, GLIMMIX) and reproducible code habits.
• Ability to start no later than 19 Aug 2025 and deliver a draft SAP within five business days.Terms
Hourly 1099 contract. Estimated 60 billable hours; any overage requires pre-approval. Invoices net 15 via ACH. Work is 100 % remote; you’ll have access to a secure GitHub repo and validated EDC.How to apply (by 14 Aug 2025)
Email ******with your two-page CV, a redacted excerpt from a recent SAP or CSR you authored, confirmation you can meet the timelines above, and your hourly rate expectation. Short-listed candidates will have a brief Zoom interview and code-review screen.Help us bring the first prescription voice-AI therapy for depression to patients—your stats expertise will make it possible.
