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Rapport Therapeutics · 2 weeks ago

Principal Statistical Programmer

Boston, MA

Full-time

Hybrid

Lead/Staff

$180K/yr - $200K/yr

8+ years exp

Rapport Therapeutics is driven by a passion for developing precision neuromedicines aimed at improving patients' lives. The Principal Statistical Programmer will lead statistical programming activities across all stages of clinical development, ensuring compliance with industry standards and providing oversight for regulatory submissions.

BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine

Responsibilities

Lead Statistical Programming activities across all stages of clinical development (Phase I-IV), from protocol development design to clinical study report (CSR), health agency submission and post-marketing activities

Review and understand study documents, including the Protocol, electronic case Report Forms (eCRFs), Statistical Analysis Plans (SAPs) and CSR

Have strong technical hands-on experience of SAS base/graph/stat programming skills on CDISC SDTM/ADaM specification, datasets and and TFL (tables, listings, figures) generation/validation

Ensure compliance with industry standards (CDISC, ICH, FDA/EMA guidance) and company SOPs

Provide programming oversight for regulatory submissions (e.g., NDA/BLA/MAA), including eCTD packages, define.xml, and reviewer guides (cSDRG and ADRG)

Lead the development and implementation of programming standards, automation tools, and quality control processes

Serve as a subject matter expert for programming strategy, data standards, and regulatory expectations

Collaborate with Biostatistics leadership to ensure integration of statistical and programming workflows

Hire, manage and coach different level stat programmers to establish a strong and motivated statistical programming team

Manage outsourcing strategy and oversee deliverables from CROs and external vendors

Contribute to cross-functional initiatives to improve data quality, efficiency, and innovation in clinical development

Qualification

SASCDISC standardsStatistical programmingRegulatory submissionsClinical trial processesGCPProject managementTeam leadershipRPythonNeurology experienceInterpersonal skillsCommunication skillsLeadership skills

Required

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

8-10+ years of experience in statistical programming within the biotech/pharmaceutical industry

Proven ability to build, lead, and develop high-performing programming teams, with a demonstrated track record of mentoring talent, fostering a collaborative culture, and aligning team objectives with broader organizational goals

Expert-level proficiency in SAS (Base, Macro, STAT, GRAPH) and experience with CDISC standards (SDTM, ADaM)

Proven track record of supporting successful regulatory submissions (e.g., NDA, BLA, MAA)

In-depth knowledge of clinical trial processes, GCP, regulatory requirements (FDA, EMA), and ICH guidelines

Strong project management skills and ability to manage multiple priorities in a fast-paced environment

Experience managing and developing high-performing teams, both internal and external (CRO/vendor)

Excellent interpersonal, communication, and leadership skills