Senior Statistical Programmer

Bioforum; Newton (MA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

An established industry player is seeking an experienced statistical programmer to join their growing Biometrics department. This role offers the flexibility of office-based or remote work while focusing on clinical trials. Responsibilities include preparing clinical data for submission, managing project timelines, and mentoring junior team members. The ideal candidate will possess a strong background in statistical programming, particularly with CDISC standards, and excellent communication skills. Join a dynamic team where your expertise will contribute to impactful clinical research and data analysis, ensuring the highest standards of quality and compliance.

Qualifications

• 6+ years of experience in statistical programming for clinical trials.
• Strong knowledge of CDISC standards and TFL programming.

Responsibilities

• Participate in statistical programming activities for clinical data submission.
• Manage project timelines, scope, budget, and resources.
• Train and mentor the statistical programming team.

Skills

Statistical Programming

TFL Programming

CDISC Standards (SDTM, ADaM)

Attention to Detail

Excellent Communication Skills

Education

Bachelor's Degree in Statistics

Bachelor's Degree in Computer Science

Bachelor's Degree in Life Science

Tools

SAS

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 (office based or remote).

Required skills:

• Minimum 6 years' experience as a statistical programmer 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 for submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs, and taking part in creating best practices and implementation guides.
• 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.).
• 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.