Senior Statistical Programmer

Actalent is seeking a contract Senior Statistical Programmer to provide comprehensive programming support for ongoing studies and submissions in Princeton, NJ.

About the role

This hybrid position requires working in the office at least two days a week. The company is a leading global specialty pharmaceutical and biotechnology entity with headquarters in Tokyo, Japan, expanding its global presence with a new U.S. manufacturing site in North Carolina. The work environment supports innovation in biologics and gene- and cell-based therapies, emphasizing patient-focused advancements and strategic partnerships.

Responsibilities

• Independently manage and support multiple global studies simultaneously with minimal oversight.
• Oversee programming tasks, including SDTM, ADaM, and TLF preparation performed by vendors, while managing internal statistical programming activities.
• Collaborate with vendors to ensure accurate programming for analysis and regulatory submissions.
• Participate in project teams, review protocols, statistical analysis plans, and clinical study reports.
• Provide programming support to the data management team, including data reconciliation.
• Assist in identifying and maintaining department procedures and contribute to process improvement initiatives.
• Coordinate with Japanese colleagues to align on global programming procedures and standards.
• Assist in regulatory submissions and support responses to regulatory authority requests.
• Provide expertise in FDA/EMA guidances related to electronic format submissions.
• Ensure compliance with ICH/GCP guidelines and CDISC standards for data structures and validation.

Requirements

• Minimum eight years of extensive experience in statistical programming for clinical trials in the pharmaceutical or life sciences industry.
• Expertise in Base SAS, SAS/STAT, SAS/GRAPH, Reporting and Graphical Procedures, Macro, and SAS Version 9.2 or higher.
• Experience with CDISC SDTM/ADaM standards and regulatory submission requirements.
• Proficiency in FDA/EMA regulatory submissions, including CSR support.
• Experience in safety reporting and data integration for ISS/ISE across multiple studies.

Qualifications

• Master’s Degree in Computer Science, Data Science, Health Science, Statistics, or a related discipline.
• Preferred experience with R and/or Python.
• Experience with SAS-LSAF (Life Science Analytics Framework) is preferred.
• Strong proficiency in Microsoft Office applications.
• Ability to organize, prioritize, meet deadlines, and work in a dynamic environment.
• Strong interpersonal and communication skills.
• Cultural sensitivity and ability to develop consensus within a multinational organization.

Pay

The pay range for this position is $70.00 - $80.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

If eligible, benefits for this temporary role may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a hybrid position based in Princeton, NJ, requiring in-office work at least two days a week.