Lead Statistical Programmer - SDTM/ADaM, CRO Oversight

Connect Life Sciences

Cambridge (MA)

On-site

USD 180,000 - 280,000

Full time

2 days ago

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Job summary

Connect Life Sciences in Cambridge, MA seeks an experienced AD/Director, Statistical Programming to lead statistical programming across multiple clinical programs, including upcoming phase 2 studies. You will oversee CRO deliverables for SDTM, ADaM, and TLFs, develop and validate datasets, and collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory affairs.

The role reports to Senior Director, Statistical Programming; no short-term direct reports; strong growth

Qualifications

Must haves: Hands-on clinical trial experience with SDTM, ADaM, and TLFs; Strong proficiency in developing and debugging SAS macros and utilities; Ability to manage and review CRO deliverables for quality and compliance; Regulatory submission experience.

Responsibilities

Oversee CRO deliverables, focusing on technical quality, consistency, and documentation, particularly for SDTM, ADaM, and TLFs.
Develop, validate, and maintain datasets (SDTM, ADaM), tables, listings, and figures in line with regulatory and internal standards.
Coordinate data transfers and output deliveries, acting as lead or support programmer.
Collaborate cross-functionally with Biostatistics, Data Management, and Clinical Operations to align timelines and quality expectations.
Work on a Program, especially upcoming phase 2 studies (AD and AS studies).