Senior Statistical Programmer (North America)

Bioforum the Data Masters; Newton (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Bioforum the Data Masters in the United States is seeking an experienced statistical programmer to join our Biometrics department. The role focuses on preparing clinical data for submission using CDISC standards and SAS programming to generate analysis datasets and outputs.

Responsibilities include mentoring team members, reviewing data conversions, developing programming specifications, and ensuring timely delivery in line with SAPs and client expectations.

Qualifications

• Bachelor’s degree in statistics, computer or life science.
• 6+ years of experience in statistical programming for clinical trials.
• Proficient in SAS programming for CDISC data standards (SDTM/ADaM).
• Experience preparing submission documents (Reviewer’s Guide, Define.xml).
• Detail-oriented with strong communication.

Responsibilities

• Prepare clinical data for submission using CDISC standards.
• Develop SAS programs for SDTM/ADaM datasets and analyses.
• Create programming specification documents and validate conversions.
• Mentor and train junior programmers and support project timelines.

Skills

Attention to detail

Excellent communication

Education

Bachelor’s degree in statistics, computer or life science

Tools

SAS

CDISC SDTM/ADaM

Define.xml

Reviewer’s Guide

Job description

The Bioforum Biometrics department is growing, and we have an opportunity for an experienced statistical programmer to join our group. This position is in the United States of America (North America).

Required skills

• Minimum 6 years’ experience as a statistical programming working on clinical trials.
• Good knowledge of TFL programming.
• Experience in programming according to CDISC standards (SDTM, ADaM), and preparing documents for submission (Reviewer’s Guide, Define.xml)
• Attention to details.
• Excellent communication skills.
• A bachelor’s degree in either statistics , computer or life science discipline

Duties will include

• Participating in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.
• Might need to be responsible for project management (timelines, scope, budget, resourcing) on a project or program level.
• Train, mentor and share knowledge with the rest of the statistical programming team.
• Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc.).
• Might include Interaction with customers on a project or program level.
• Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.
• Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.
• Development of SAS programs for study TFLs, based on study SAP and shells.
• Review and verify all types of conversions and programming done based on customer requirements.
• Development of core programs for validation, conversion, and maintenance of clinical data dataset structure.
• Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.