Senior Statistical Programmer

i-Pharm Consulting; New Jersey; On-site; USD 120,000 - 160,000; Full time

Job summary

i-Pharm Consulting seeks an experienced Senior Statistical Programmer to support clinical studies and regulatory submissions within a fast-paced biotech environment. You will develop and validate SDTM/ADaM datasets, produce TFLs, and contribute to SAPs while collaborating with cross-functional teams.

The role requires strong SAS programming skills, hands-on CDISC experience, and a track record of delivering high-quality outputs for regulatory submissions.

Qualifications

• Bachelor's degree in Mathematics, Statistics, Computer Science or a related field.
• Proven experience with SAS programming in clinical studies.
• Hands-on experience with CDISC standards (SDTM/ADaM) and regulatory submissions.

Responsibilities

• Provide statistical programming support across clinical studies and regulatory submissions.
• Develop, maintain, and validate CDISC-compliant SDTM and ADaM datasets.
• Produce and validate Tables, Figures, and Listings (TFLs) for clinical studies and analyses.
• Create dataset specifications in accordance with SDTM IG, ADaM IG, and SAPs.
• Design, develop, test, and implement programming solutions to meet complex business requirements.
• Develop, maintain, and enhance SAS macros and other programming utilities.
• Perform ad-hoc, exploratory, and validation analyses as required.
• Collaborate with cross-functional teams and study teams to deliver results on time.
• Manage multiple projects with high quality within strict timelines.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Clinical data analysis

Communication skills

Education

Bachelor's degree in Mathematics, Statistics, Computer Science

Tools

Python

VBA

SAS Macros

Job description

We are currently seeking an experienced Senior Statistical Programmer to join a leading pharmaceutical/biotechnology organisation. This is an exciting opportunity for a highly skilled programmer to support clinical studies and regulatory submissions while working within a collaborative, fast-paced environment.

Key Responsibilities

• Provide statistical programming support across clinical studies and regulatory submissions.
• Develop, maintain, and validate CDISC-compliant SDTM and ADaM datasets.
• Produce and validate Tables, Figures, and Listings (TFLs) for clinical studies, publications, and ad-hoc analyses.
• Create dataset specifications in accordance with SDTM IG, ADaM IG, and Statistical Analysis Plans (SAPs).
• Design, develop, test, and implement programming solutions to meet complex business requirements.
• Develop, maintain, and enhance SAS macros and other programming utilities.
• Perform ad-hoc, exploratory, and validation analyses as required.
• Collaborate effectively with cross-functional teams, stakeholders, and study teams.
• Manage multiple projects simultaneously while delivering high-quality work within strict timelines.

Required Skills & Experience

• Proven experience within the pharmaceutical, biotechnology, or related life sciences industry.
• Advanced SAS programming expertise.
• Hands-on experience with CDISC standards, including SDTM and ADaM.
• Experience producing and validating clinical study datasets and outputs.
• Excellent verbal and written communication skills.
• Strong problem-solving abilities and attention to detail.
• Ability to work independently while contributing effectively within a team environment.
• Previous regulatory submission experience.
• Experience with additional programming languages such as Python, VBA, C++, or similar.
• Experience working within project-based contract environments.

Education

• Bachelor's degree in Mathematics, Statistics, Computer Science, or a related field.