Statistical Programmer

Connect Life Sciences; Cambridge (MA); On-site; USD 180,000 - 280,000; Full time

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).

Education

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

Tools

SAS

R

Python

Job description

***WE CANNOT USE 3rd PARTIES FOR THIS ROLE***

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)

Who does this report to? Will this person have direct reports? Who will this person collaborate with?

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

What is exciting about the role that I can share with candidates??

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.?

Qualifications?

Education + years of experience – are you flexible with these??

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)

What are the must haves versus nice-to-haves in terms of technical skills experience??

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

What non-technical skills are you looking for??

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;

Will this person be required to be onsite 5 days/week?