Statistical Programmer

The AD or Director, Statistical Programming role was opened to support our growing clinical portfolio and increasing data complexity, particularly as programs into later-stage development. This role is part of our broader strategy to scale the programming function in alignment with our clinical and regulatory priorities

• What is this person responsible for day-to-day? What projects will they work on??
• 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

Etc.

They will work on a Program, especially upcoming phase 2 studies (AD and AS studies)

This role will report to Senior Director, statistical programming;

This person will not have direct reports in short term, expect in long term;

This person will collaborate with Biostatistics, Data Management, Clinical Scientists, Translational medicine team (PD team), Regulatory affairs, IT team, Quality Team, external vendors, etc

the team operates in a?collaborative and fast-paced environment

Strategic Impact Across a Growing Pipeline:
This role offers the opportunity to lead statistical programming efforts across multiple clinical programs, including high-priority assets like KT-621.

Cross-Functional Visibility and Influence:
The role is highly collaborative, interfacing with Biostatistics, Data Management, Clinical Operations, and external partners.

Culture of Agility and Excellence:
Our client fosters a fast-paced, mission-driven environment where adaptability, curiosity, and collaboration are deeply valued. The programming team is scaling with intention, and this role is central to that growth.

Professional Growth and Innovation:
There’s strong support for professional development—whether through conferences, regulatory workshops, or academic advancement.?

MS or equivalent degree in Statistics, Biostatistics, Computer Science, or related field.

8+ years of experience in statistical programming in the pharmaceutical or biotech industry. (7+ years of experience for Senior Manager)

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;

Nice-to-haves:
Experience with PD/PK data workflows;
Knowledge of R or Python

Comfort working with?diverse teams;
Excellent verbal and written communication skills; A proactive mindset;
The ability to?navigate ambiguity and quickly adapt to evolving priorities and technologies;