Remote Senior Statistical Programmer – Short-Term Contract

Fives DyAG Corp.; Florham Park (NJ); Remote; USD 2,459,000 - 3,327,000; Full time

Benefits offered by this job

401K

Dental insurance

Life Insurance

Medical Insurance

Vision Insurance

PTO

Job summary

On-Board Services, Incorporated is seeking a remote Senior Statistical Programming Contractor to provide expert-level support across clinical and device studies, regulatory submissions, and exploratory analyses. This 3-month contract offers exposure to SDTM/ADaM, Define.xml, and submission-ready datasets.

The role requires 10+ years in pharmaceutical/biotech/CRO environments, SAS programming mastery, macro development, and strong collaboration with biostatistics and data management teams.

Qualifications

• 10+ years of hands-on statistical programming in pharma/biotech/CRO.
• Advanced knowledge of GCP/ICH guidelines and FDA submissions.
• Expert SAS programming including macro development.
• Strong CDISC SDTM/ADaM Define.xml and submission-ready data sets.
• Experience supporting regulatory submissions and publications.
• Familiarity with R and/or Python for analyses is desirable.
• Strong project management and cross-functional collaboration.

Responsibilities

• Provide expert-level statistical programming across clinical and device studies and regulatory submissions.
• Develop and maintain SAS programs to generate SDTM/ADaM datasets and TLFs.
• Write and review specifications for SDTM/ADaM datasets.
• Perform QC of programming deliverables for accuracy and regulatory compliance.
• Collaborate with biostatistics and data management to support trials and publications.
• Develop standard macros and templates to improve efficiency.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions (FDA/ICH)

Statistical programming

GCP/ICH guidelines

R/Python (desirable)

Project management

Cross-functional collaboration

Communication skills

Job description

On-Board Services, Incorporated is seeking a remote Senior Statistical Programming Contractor to provide expert-level support across clinical and device studies, regulatory submissions, and exploratory analyses. This 3-month contract offers exposure to SDTM/ADaM, Define.xml, and submission-ready datasets.

The role requires 10+ years in pharmaceutical/biotech/CRO environments, SAS programming mastery, macro development, and strong collaboration with biostatistics and data management teams.