Senior Statistical Programmer

Redbock - an NES Fircroft company

United States

Remote

USD 103,320 - 121,228

Full time

14 days+

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Benefits offered by this job

Medical insurance
Vision insurance
401(k)
Disability insurance

Job summary

A clinical research consulting firm is seeking a Senior Statistical Programmer to work remotely. This role involves SAS programming for clinical trial submissions and collaboration with statisticians and vendors. The ideal candidate will have over 10 years of experience and expertise in Oncology. Key benefits include medical and vision insurance, 401(k), and disability insurance.

Qualifications

  • 10+ years of experience in statistical programming.
  • Strong SAS programming skills required.
  • Experience integrating ISS/ISE data is necessary.
  • Regulatory submission experience is required.

Responsibilities

  • Develop SAS programs for analyzing clinical trials.
  • Maintain macros and tools for the Biometrics group.
  • Interact with Lead Programmer and Statisticians.
  • Support ISS and NDA including BIMO.
  • Collaborate with external vendors on deliverables.

Skills

SAS programming skills
Expertise in CDISC (SDTM and ADaM)
Communication skills
Oncology therapeutic area expertise

Job description

Location: Remote, with flexibility to accommodate urgent deliverables during PT hours, if needed

Pay rate: $75-80/hour W2; $80-88 C2C

Summary: Our small Oncology client on the West Coast is seeking a Senior Statistical Programmer to support clinical trial submissions. This role will be responsible for SAS programming for SDTM, ADaM, and TLFs, support ISS/ISE and regulatory submissions (including BIMO), and collaborate closely with statisticians, lead programmers, and external vendors. This consultant will need to be comfortable working in a small‑team environment.

Primary Responsibilities:

  • Develop SAS programs to generate and/or validate SDTM, ADaM & TLFs for analyzing clinical trials, supporting registrations, and creating reports for publications and other ad‑hoc analyses.
  • Develop, validate and maintain macros and tools for general use within the Biometrics group to enhance the efficiency and quality of output produced.
  • Draft and/or review data specifications for SDTM, ADaM & TLFs.
  • Interact with Lead Programmer & Statisticians on status updates, timelines and content of deliverables.
  • Support ISS and NDA including BIMO (datasets, define, reviewers guide).
  • Collaborate with external vendors on Biometrics’ deliverables and provide quality oversight.

Experience Required:

  • 10+ years of experience in statistical programming.
  • Strong SAS programming skills, including expertise with CDISC (SDTM and ADaM) & TLF programming.
  • Must have strong experience integrating ISS/ISE data.
  • Oncology therapeutic area expertise is required.
  • Regulatory submission experience (NDA/BLA, BIMO).
  • Ability to QC programming work from CROs.
  • Strong communication skills with the ability to interface at all levels & comfortable communicating workload to assist in managing priorities.
  • Knowledge of R is a plus.

Benefits:

  • Medical insurance
  • Vision insurance
  • 401(k)
  • Disability insurance
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