Study Lead Statistician - Product Facing

Location:

Fully Remote (US Mainland; must align to Eastern Time)

Hours:

Monday–Friday, 8 AM – 5 PM ET

Pay Rate:
Up to $113/hour

Our confidential client is seeking a Study Lead Statistician (SLS) to lead statistical activities for product‑facing clinical studies. The SLS works cross‑functionally to ensure studies are well‑designed, statistically powered for success, and compliant with regulatory standards and company procedures. This role partners closely with the Global Statistical Lead to align study‑level work with overall product strategy and supports product‑level activities such as regulatory submissions and publications.

• Provide statistical guidance, review, and contributions to protocols, SAPs, TFL shells, DMC charters, SDTM and ADaM specifications, and randomization specifications.
• Attend and contribute to Clinical Study Team meetings; provide statistical input into cross‑functional start‑up activities including CRF and database review, and IVRS specification review.
• Initiate and lead cross‑functional meetings for SAP, TFL, and results review.
• Perform and document QC of key endpoints within ADaM datasets and statistical analyses.
• Conduct data‑driven modeling and statistical simulations during study execution.
• Review TFLs created by programming for consistency and accuracy.
• Author statistical sections of analysis reports, flash memos, and CSR results.
• Collaborate with programming, data management, medical writing, and clinical operations for deliverables.
• Manage study timelines for all statistics‑related deliverables.
• Support product‑level publication requests and participate in audits as needed.

• M.S. degree in Statistics, Biostatistics, or a related field with at least 5 years of post‑graduate statistical experience, or Ph.D. with at least 2 years of experience.
• Hands‑on experience in the design, analysis, and reporting of clinical trials within a pharmaceutical, biotechnology, or medical research environment.
• Strong understanding of statistical principles and methodologies for clinical study design and analysis.
• Proven ability to lead statistical activities independently for at least one complex or multiple moderate studies.
• Strong SAS and/or R programming skills for simulations and statistical analyses.
• Excellent written and verbal communication skills; ability to convey complex statistical concepts clearly.

• M.S. with 6+ years or Ph.D. with 5+ years of experience in the pharmaceutical/biotech industry.
• Demonstrated experience presenting and defending statistical approaches and results in internal and external meetings (e.g., investigator, steering, advisory board, or regulatory).
• Proven record of effective cross‑functional collaboration with programming, data management, and clinical development teams.
• Experience supporting publication activities and regulatory submissions.