Sr Statistical Programmer, Oncology

Connect Life Sciences; Bridgewater (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Connect Life Sciences is seeking an experienced Statistical Programmer to drive data preparation and submission-ready datasets for clinical programs in a fast-paced environment. You will develop SAS programs, ensure CDISC SDTM/ADaM compliance, author Define.xml and analysis datasets, and mentor junior team members.

This on-site role in Bridgewater, MA offers collaboration across study teams, adherence to SOPs and opportunities to influence standard practices.

Qualifications

• Minimum 8 years’ experience as a statistical programmer 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)

Responsibilities

• Participate in statistical programming activities and prepare submission-ready data using CDISC or custom standards.
• Assist in project timelines, scope, budget, and resourcing.
• Train, mentor and share knowledge with the programming team.
• Create programming specs for SDTM, ADaM and derived data.
• Interact with customers on project level when required.
• Develop SAS programs for data conversion according to CDISC or customer instructions.
• Develop SAS programs for analysis datasets based on SAP and shells.
• Develop SAS programs for study TFLs per SAP.
• Review and verify all conversions and programs against requirements.
• Follow SOPs for all statistical programming activities.

Skills

SAS programming

TFL programming

CDISC SDTM/ADaM

Submission documents/Define.xml

Education

Bachelor’s degree in statistics, computer or life science

Tools

SAS

Job description

• 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.

Qualifications

• A bachelor’s degree in either statistics , computer or life science discipline

Required Skills

• Required skills:
• Minimum 8 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)