Principal Statistical Programmer Submissions

Role Overview

We are seeking an experienced Principal Statistical Programmer to support regulatory submission activities within the Submissions Group (Center of Excellence). The role requires strong expertise in CDISC standards, ISS preparation, and eCRT deliverables, along with advanced SAS programming skills.

The ideal candidate will have in-depth knowledge of clinical trial data standards and experience supporting global regulatory submissions.

Key Responsibilities

• Lead and execute programming activities for regulatory submissions

• Develop and validate submission deliverables including:

• ISS / ISE outputs

• ECRT packages (aCRF, define.xml, CSDRG)

• Perform high-quality SAS programming for SDTM, ADaM, and TFLs.

• Ensure compliance with CDISC standards and regulatory guidelines.

• Support BIMO-related programming activities (if applicable).

• Review and QC programming outputs to ensure accuracy and submission readiness.

• Interpret complex clinical trial data and resolve data-related queries.

• Work independently and lead programming assignments within timelines.

• Document key decisions and maintain submission documentation.

Required Qualifications & Skills

• Strong SAS programming expertise.

• Extensive clinical trial experience (Phase IIII preferred).

• Strong knowledge of CDISC standards (SDTM, ADaM).

• Hands-on experience with:

• ISS/ISE preparation

• ECRT packages (aCRF, define.xml, CSDRG)

• Solid understanding of regulatory submission processes.

• Ability to lead projects and work independently.

• Strong analytical and problem-solving skills.

• Excellent communication skills.

Preferred Qualifications

• P21 experience.
• BIMO submission experience.
• R programming knowledge.
• Prior experience in a Submissions or Regulatory Center of Excellence.

Candidate Profile

• Detail-oriented and quality-driven.
• Strong documentation and compliance mindset.
• Capable of managing multiple priorities in a submission-driven environment.

Apply today!

Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

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