Associate Director, Biostatistics — Hybrid Leader

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 144,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Discretionary annual bonus

Restricted stock units (RSUs)

Job summary

Rhythm Pharmaceuticals Inc. in Boston seeks an Associate Director, Biostatistics to lead statistical activities across clinical programs. You will design studies, develop SAPs, and present robust analyses in collaboration with clinical, safety, data management, and programming teams.

The role requires advanced degrees with extensive trial experience, proficiency in SAS and R, and familiarity with CDISC standards. Hybrid work is offered, with some travel to support global submissions.

Qualifications

• PhD with 5+ years of clinical trial biopharma/biotech/CRO experience or MS with 8+ years.
• Strong grasp of statistical concepts and trial methodologies.
• Experience supporting regulatory submissions (IND/NDA/BLA/MAA/J-NDA) is preferred.
• Familiarity with CDISC standards (SDTM/ADaM).

Responsibilities

• Serve as statistical lead for assigned studies, including design, SAPs, TLFs, and analyses.
• Collaborate with cross-functional teams for strategy, execution, and decision-making.
• Prepare statistical content for protocols, CSRs, and integrated summaries.
• Oversee statistical vendors and QC of outputs per Rhythm standards.
• Review outputs with statistical programmers to ensure timely resolution.
• Support interim analyses, DSMB meetings, and other statistical activities.
• Contribute to statistical sections of regulatory submissions.
• Support CRFs, data management plans, and data review activities.
• Help improve departmental standards and processes.

Skills

SAS

R

CDISC SDTM/ADaM

Regulatory submissions

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

EAST

Job description

Rhythm Pharmaceuticals Inc. in Boston seeks an Associate Director, Biostatistics to lead statistical activities across clinical programs. You will design studies, develop SAPs, and present robust analyses in collaboration with clinical, safety, data management, and programming teams.

The role requires advanced degrees with extensive trial experience, proficiency in SAS and R, and familiarity with CDISC standards. Hybrid work is offered, with some travel to support global submissions.