Statistical Programmer

Systimmune • Princeton, NJ

1d • $80,000 - $100,000 • Hybrid

About The Position

The Statistical Programmer will support statistical programming activities for clinical trials, including generating SDTM and ADaM datasets, tables, figures, and listings (TFLs). This early-career role offers the opportunity to learn and grow in a fast-paced biotech environment while gaining exposure to end-to-end clinical development. The position is hybrid, with a minimum of three days onsite at the Princeton, New Jersey office.

Requirements

• Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific discipline.
• 0–2 years of experience in statistical programming within the pharmaceutical/biotech industry or a CRO.
• Proficiency in SAS programming, preferably with experience in a clinical trial environment.
• Working knowledge of CDISC standards, including SDTM and ADaM.
• Hands-on experience developing and validating SDTM and ADaM datasets and statistical outputs, including tables, figures, and listings.
• Strong analytical, problem-solving, and organizational skills.
• Effective communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.

Nice To Haves

• Prior experience or exposure to oncology studies.

Responsibilities

• Collaborate with biostatisticians and cross-functional study team members to deliver statistical analysis and reporting outputs within project timelines.
• Review study documents, including statistical analysis plans (SAPs), CRFs, database specifications, and data transfer specifications.
• Create and/or review SDTM/ADaM mapping specifications and annotated CRFs (aCRFs).
• Generate and/or validate SDTM and ADaM datasets, including Define.xml and reviewer’s guides.
• Develop and validate tables, figures, and listings (TFLs) for clinical study analyses, regulatory submissions, conferences, and publications.
• Assess the quality, integrity, and consistency of analysis datasets, including cross-study analyses where applicable.
• Develop SAS programs and macros to automate dataset generation and reporting deliverables.
• Contribute to process improvements and enhancements of the statistical programming environment.
• Participate in study team meetings and represent statistical programming in cross-functional discussions.
• Apply knowledge of clinical trial design, CDISC standards, and regulatory requirements to produce analysis datasets and outputs in compliance with SOPs and industry standards.

Benefits

• 100% paid employee premiums for medical, dental, and vision insurance.
• Short-term disability (STD) and long-term disability (LTD).
• 401(k) plan with a 50% company match of up to 3%, with a five-year vesting schedule.
• 15 PTO days per year.
• Sick leave.
• 11 paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level