Statistical Programmer

Base SAS Visionary Innovation Statistics Data Science Communication Life Sciences Biotechnology SAS (Software) Pharmaceuticals Clinical Trials Data Structures Data Management Health Sciences Microsoft Office Computer Science Data Integration Biopharmaceuticals Process Improvement Intravenous Therapy Statistical Analysis Strategic Partnership Artificial Intelligence Statistical Programming R (Programming Language) Ability To Meet Deadlines Engineering Design Process Good Clinical Practices (GCP) Cisco Identity Services Engine (ISE), The Senior Statistical Programmer will provide comprehensive programming support for ongoing studies and submissions. This role involves creating and validating datasets and TLFs, managing vendor oversight, and performing sponsor reviews of deliverables. Additionally, the Senior Statistical Programmer will create patient profiles, provide ad-hoc programming support, represent programming on project study teams, and collaborate with both in-house staff and external vendors to establish and maintain global programming standards. 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., Base SAS Visionary Innovation Statistics Data Science Communication Life Sciences Biotechnology SAS (Software) Pharmaceuticals Clinical Trials Data Structures Data Management Health Sciences Microsoft Office Computer Science Data Integration Biopharmaceuticals Process Improvement Intravenous Therapy Statistical Analysis Strategic Partnership Artificial Intelligence Statistical Programming R (Programming Language) Ability To Meet Deadlines Engineering Design Process Good Clinical Practices (GCP) Cisco Identity Services Engine (ISE) +0 Login | JoinContact

• 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., * 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.

This 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, and is 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. The organization values a collaborative culture and offers opportunities for international travel. Job Type & Location

This is a Contract position based out of Princeton, NJ. Pay and Benefits

The pay range for this position is $70.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 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) Workplace Type

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.