Lead Principal Statistical Programmer – CSRs & Submissions

Planet Pharma; New Jersey; Hybrid; USD 150,000 - 230,000; Full time

Job summary

Planet Pharma is seeking a Senior Statistical Programmer Leader to guide complex programming projects, provide technical oversight, and mentor junior staff. The role covers SDTM/ADaM development, regulatory submission support, and quality control of deliverables.

The position requires hands-on programming with SAS and related tools, plus leadership in project management and client communication. On-site NJ for collaboration with cross-functional teams.

Qualifications

• Experience leading complex statistical programming projects.
• Ability to provide training and mentorship to less experienced programmers.
• Experience developing and reviewing SDTM/ADaM datasets and related specifications.
• Perform QC/validation of regulatory submission programming documents and outputs.

Responsibilities

• Lead projects with high complexity and drive on-time, high-quality deliverables.
• Provide technical leadership and mentorship to statistical programming teams.
• Represent the company in client interactions regarding programming oversight and proposals.
• Interact with regulatory agencies as needed.
• Develop and maintain SDTM/ADaM specifications and datasets, and review TLGs for CSR/ISS/ISE.

Skills

Leadership

Project management

Statistical programming

SAS

Mentorship

Quality control

Regulatory submissions

Define/define.xml

Tools

InForm

MediData Rave

DFdiscover

SAS

Excel

Job description

Planet Pharma is seeking a Senior Statistical Programmer Leader to guide complex programming projects, provide technical oversight, and mentor junior staff. The role covers SDTM/ADaM development, regulatory submission support, and quality control of deliverables.

The position requires hands-on programming with SAS and related tools, plus leadership in project management and client communication. On-site NJ for collaboration with cross-functional teams.