Senior Statistical Programmer

Actalent; Princeton (NJ); Hybrid; USD 96,000 - 110,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short/Long-term Disability

HSA

Job summary

Actalent is seeking a Senior Statistical Programmer to provide comprehensive programming support for global studies and regulatory submissions. You will create datasets and TLFs, oversee vendor work, and ensure programming standards are met across teams.

You will contribute to patient profiles, ad-hoc analyses, and sponsor reviews. Ideal candidates will have 8+ years of clinical trials programming experience, strong SAS skills (Base, SAS/STAT, SAS/GRAPH, Macro), and familiarity with CDISC

Qualifications

• This role requires a minimum of eight years of extensive statistical programming experience in clinical trials.
• Expertise with CDISC SDTM/ADaM and regulatory submission requirements is essential.
• Experience with FDA/EMA submissions and ISS/ISE data integration is preferred.

Responsibilities

• Independently manage and support multiple global studies with minimal oversight.
• Oversee vendor programming tasks (SDTM, ADaM, TLF) and internal activities.
• Collaborate with vendors to ensure accurate analyses for regulatory submissions.
• Review protocols, SAPs, and CSR documents as part of study teams.
• Provide programming support to data management, including data reconciliation.
• Contribute to process improvement and standardization across global programming.
• Coordinate with international colleagues to align programming standards.
• Assist in regulatory submissions and respond to regulatory authority requests.

Skills

Base SAS

SAS/STAT

SAS/GRAPH

SAS Macro

CDISC SDTM/ADaM

Regulatory submissions

Data integration

Vendor oversight

Education

Master's Degree in Computer Science, Data Science, Health Science, Statistics, or related field

Tools

SAS-LSAF

R

Python

Job description

Job Title: Senior Statistical ProgrammerJob Description

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.

Essential Skills

• 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.

Additional Skills & 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.

Work Environment

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.

• 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

This is a hybrid position in Princeton,NJ.

Application Deadline

This position is anticipated to close on Aug 26, 2026.

About Actalent

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.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.