Senior Manager, Statistical Programming — Biotech

Rapport Therapeutics; Boston (MA); Hybrid; USD 200,000 - 220,000; Full time

Benefits offered by this job

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Job summary

Rapport Therapeutics in Boston seeks Senior Manager/AD of Statistical Programming to lead clinical trial programming and ensure high-quality data outputs across development programs.

You will oversee SAS programming for SDTM/ADaM, manage CROs, ensure regulatory submission readiness, and mentor a growing team within the Biometric groups.

This hybrid role requires onsite Mon-Wed in Boston, with strong CDISC, ICH, FDA/EMA guidance experience and a strategic mindset.

Qualifications

• Master’s or Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• 8-10 years of statistical programming experience in biotech/pharmaceutical/CRO.
• Expert-level SAS (Base, Macro, STAT, GRAPH) proficiency; CDISC SDTM/ADaM experience.
• Strong SP project management skills and ability to manage multiple priorities.
• Knowledge of GCP, regulatory requirements (FDA, EMA), ICH guidelines.
• Experience managing internal and external (CRO/vendor) teams.
• Experience supporting regulatory submissions (NDA, BLA, MAA) is preferred.
• Familiarity with R, Python, or other languages.
• Neurology or CSN domain experience is highly desirable.

Responsibilities

• Lead statistical programming activities across all stages of clinical development.
• Develop, validate, and document SAS programs for SDTM, ADaM, and TFL outputs.
• Oversee outsourcing strategy and CRO/vendor deliverables.
• Ensure compliance with CDISC, ICH, FDA/EMA guidance and SOPs.
• Provide programming oversight for regulatory submissions and packages (eCTD, define.xml, reviewer guides).
• Collaborate with Biostatistics leadership to integrate workflows and mentor the team.

Skills

SAS proficiency

CDISC SDTM/ADaM

SP project management

Regulatory submissions

R or Python

Team leadership

GCP knowledge

Neurology CSN domain

Education

Master’s or Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences or related field

Job description

Rapport Therapeutics in Boston seeks Senior Manager/AD of Statistical Programming to lead clinical trial programming and ensure high-quality data outputs across development programs.

You will oversee SAS programming for SDTM/ADaM, manage CROs, ensure regulatory submission readiness, and mentor a growing team within the Biometric groups.

This hybrid role requires onsite Mon-Wed in Boston, with strong CDISC, ICH, FDA/EMA guidance experience and a strategic mindset.