Senior Statistical Programming Lead (Remote/Hybrid)

Servier Group; Boston (MA); Hybrid; USD 165,000 - 200,000; Full time

Job summary

Servier in the U.S. seeks an Associate Director, Statistical Programming to lead programming activities for multiple studies or assets, ensuring regulatory compliance and high-quality outputs.

The role combines hands-on programming with oversight of outsourced work and collaboration with statisticians and CROs. The ideal candidate holds a master's in statistics or a related field, 8+ years in pharma statistical programming, expert SAS skills, and a strong command of CDISC ADaM/SDTM.

Qualifications

• Masters in Statistics, Engineering or relevant field required with a minimum of 8 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry in clinical development desirable.
• Experience with statistical programming in Oncology desirable.
• Self-directed, technically strong, expert regarding statistical programming processes, management of statistical programmers at study level.

Responsibilities

• Manage statistical programming deliverables on one or more assets or indications by managing study leads and overseeing study activities and vendor oversight.
• Oversee development and quality control or oversight plan of analysis datasets and outputs for individual study as well as integrated analyses.
• Ensure study leads deliver high quality, traceability, reproducibility of study outputs and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.
• Mentor statistical programmers with regards to programming activities and project management.
• Independently implement routine and non-standard analysis algorithms for assigned projects or studies.
• Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.
• Ensure an efficient collaboration with all members of the clinical study team.
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
• Clinical study reporting, e.g., ICH E3
• Electronic records handling, e.g., Chapter 21 of the US Code of Federal Regulation – Part 11
• Electronic submission of clinical data to agencies, e.g., e-CTD guidance and CDISC SDTM and ADaM standards.
• Ensure that the datasets (SDTMs and ADaMs) are CDISC compliant.
• Support on the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to achieve the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.
• Work with the portfolio programming lead to create forecasts for different studies and resource requirements.

Skills

SAS

CDISC ADaM/SDTM

Regulatory knowledge

Job management

CRO collaboration

Leadership

Education outreach

Team coordination

Education

Masters in Statistics or related field

Tools

SAS

Job description

Servier in the U.S. seeks an Associate Director, Statistical Programming to lead programming activities for multiple studies or assets, ensuring regulatory compliance and high-quality outputs.

The role combines hands-on programming with oversight of outsourced work and collaboration with statisticians and CROs. The ideal candidate holds a master's in statistics or a related field, 8+ years in pharma statistical programming, expert SAS skills, and a strong command of CDISC ADaM/SDTM.