Remote R-Based Statistical Programming Lead

i-Pharm Consulting; United States; On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Fully remote US

R-based programming environment

Job summary

i-Pharm Consulting is seeking a Principal/Associate Director of Statistical Programming to lead a 100% R-based programming organization. This fully remote role in the United States offers high visibility in late-stage clinical programs and opportunities to shape automation and standards.

You will partner with Biostatistics, Clinical Development, Data Management, and CROs to drive advanced programming, data remediation, and regulatory submissions.

Qualifications

• Strong statistical programming experience in biotech/pharma.
• Advanced R programming skills.
• Experience supporting NDA, BLA, MAA submissions.
• Experience using generative AI tools, including prompt engineering.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Experience leading studies, submissions, or programming teams.
• Experience overseeing external vendors or CROs.
• Strong communication and stakeholder management skills.
• Experience with complex legacy datasets, data remediation, or data rescue projects.

Responsibilities

• Lead statistical programming activities across clinical development programs.
• Support key regulatory submissions and major development milestones.
• Develop and validate SDTM, ADaM, and analysis-ready datasets.
• Drive adoption of modern R-based programming workflows.
• Partner with Biostatistics, Clinical Operations, Data Management, and CROs.
• Support TLF generation and submission deliverables.
• Contribute to automation, standards, and process improvements.
• Act as a study lead, technical lead, or subject matter expert.

Skills

Statistical programming

Advanced R

NDA submissions

AI tools / prompt engineering

CDISC SDTM/ADaM

Lead studies / teams

Vendor / CRO oversight

Communication / stakeholder mgmt

Data remediation / data rescue

Job description

i-Pharm Consulting is seeking a Principal/Associate Director of Statistical Programming to lead a 100% R-based programming organization. This fully remote role in the United States offers high visibility in late-stage clinical programs and opportunities to shape automation and standards.

You will partner with Biostatistics, Clinical Development, Data Management, and CROs to drive advanced programming, data remediation, and regulatory submissions.