Overview

Responsibilities

Lead, mentor, and develop a team of statistical programmers, providing guidance on technical and project related matters.
Allocate resources and assign projects across studies and programs to meet corporate and clinical timelines.
Conduct performance reviews, support career development, and foster a culture of accountability and innovation.

Oversee the development, validation, and documentation of SDTM, ADaM datasets, and TLFs for clinical trials and regulatory submissions.
Act as lead programmer for high profile or complex studies, ensuring high quality deliverables.
Review and approve programming specifications and outputs, ensuring consistency and accuracy.

Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and external vendors to define data and analysis requirements.
Serve as the primary programming point of contact for internal stakeholders and regulatory authorities, as needed.
Participate in strategic planning and resource forecasting for clinical programs.

Ensure adherence to internal SOPs, ICH GCP guidelines, CDISC standards (SDTM/ADaM), and regulatory submission requirements (e.g., FDA, EMA).
Support regulatory submission activities including preparation of define.xml, reviewer's guides, and integrated summaries (ISS/ISE).
Drive process improvement and contribute to the development of global programming standards and automation tools.
Performs other duties as assigned
Complies with all policies and standards
Bachelor's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or Master's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Preferred
10+ years in statistical programming in the pharmaceutical, biotech, or CRO industry. Required
1-3 years in a management or senior team lead role. Required
Expert proficiency in SAS (Base, Macro, SQL), and strong knowledge of CDISC (SDTM/ADaM). High
Proven track record in supporting regulatory submissions (e.g., NDA, BLA, MAA). High
Strong understanding of clinical development processes and regulatory requirements. High
Excellent organizational, leadership, and communication skills. High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.

Job description provided by Emmes.
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