Associate Director of Statistical Programming

A company is looking for an Associate Director, Clinical Statistical Programming.

Key Responsibilities

Oversee and manage Statistical Programming team activities, ensuring compliance with project timelines, quality standards, and budget constraints

Provide expertise in statistical programming and data collection processes, including protocol reviews and validation plans

Develop and improve Statistical Programming strategies, standards, and processes while managing changes due to protocol amendments

Required Qualifications

BA / BS in computer science, statistics, or related field with at least 8 years of statistical programming experience in the CRO / Pharmaceutical industry

Minimum of 2 years of leadership experience managing teams, including hiring, training, and performance evaluation

Understanding of clinical trials and applicable regulatory requirements such as GCP and ICH guidelines

Extensive experience with SDTM and ADaM models, including CDISC standards and submission deliverables

Strong SAS / Base programming knowledge, with experience in developing and maintaining complex programs