Senior Statistical Programmer - Global Submissions & CDISC

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

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