Lead Statistical Programmer — SDTM/ADaM & Submissions

Cytel

Helena (MT)

On-site

USD 140,000 - 190,000

Full time

45 hours ago

Be an early applicant

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Job summary

Cytel is seeking a Principal Statistical Programmer to lead SAS programming efforts for a top pharmaceutical client, providing expert technical direction and independent execution with minimal supervision. The position emphasizes SDTM/ADaM standards, regulatory submissions, and creating and reviewing documentation, while guiding cross-functional teams to high data quality and compliance.

Applicants should have an MS in biostatistics or related field, or a BS with extensive pharma experience,

Qualifications

MS in biostatistics or related field with 8+ years in pharma.
Alternatively BS with 10+ years in pharma.
Exceptional SAS programming and SDTM/ADaM expertise.
Experience with FDA/ICH regulation and regulatory submissions.
Ability to lead, communicate, and influence across functions.

Responsibilities

Provide technical and project management leadership in SAS for complex clinical trial data.
Create, review, and approve documentation for data analysis and CDISC submission.
Ensure compliance with SOPs and FDA/ICH/GCP regulations.
Lead technical meetings with internal/external stakeholders.
Perform QC of advanced SAS code and Define.xml reviews.
Develop global utility programs and tools per standards.
Perform other duties as assigned.