Senior Statistical Programmer

Actalent; Deutschland; Vor Ort; EUR 83.000 - 95.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability (short/long-term)

Health Spending Account

Transportation benefits

Employee Assistance Program

Paid time off

Zusammenfassung

Actalent seeks a Senior Statistical Programmer to provide comprehensive programming support for global studies and regulatory submissions. You will create and validate datasets and TLFs, manage vendor oversight, and perform sponsor reviews of deliverables, while ensuring global programming standards.

The role requires 8+ years in clinical trial programming, expertise in Base SAS and CDISC standards, and experience with FDA/EMA submissions.

Qualifikationen

• Eight+ years of statistical programming experience in clinical trials.
• Expertise with Base SAS, SAS/STAT, SAS/GRAPH, and macro programming.
• Experience with CDISC SDTM/ADaM for regulatory submissions.
• Proficiency in FDA/EMA submissions and CSR support.
• Experience with safety reporting and ISS/ISE data integration.

Aufgaben

• Independently manage and support multiple global studies with minimal oversight.
• Oversee SDTM/ADaM and TLF tasks performed by vendors and internal teams.
• Collaborate with vendors to ensure accurate programming for analysis and submissions.
• Review protocols, SAPs, and clinical study reports on project teams.
• Provide programming support to data management and participate in process improvements.
• Coordinate with multinational colleagues to align global procedures and standards.
• Assist in regulatory submissions and responses to authority requests.
• Apply CDISC standards and ICH/GCP guidelines in data structures and validation.

Kenntnisse

Base SAS

SAS/STAT

SAS/GRAPH

Macro

SAS Version 9.2+

CDISC SDTM/ADaM

FDA/EMA submissions

ISS/ISE data integration

SAS-LSAF

R/Python (preferred)

Ausbildung

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

Tools

SAS-LSAF

Jobbeschreibung

Job Title: Senior Statistical Programmer

Job 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.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable 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

This is a hybrid position in Princeton,NJ.

Application Deadline

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

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.