Principal Scientist

Principal Scientist (Contract to Perm); Hybrid in office 3 days per week

Description

Reporting to the VP, Clinical Pharmacology, the Principal Scientist will work with Discovery Research and Development team members, to support PPK / PKPD / ER dataset preparation and exploratory data visualization, across early and late-stage programs.

This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

This role is a contract-to-hire position.

Responsibilities (including, but not limited to) :

• Clean PK / Immunogenecity related datasets
• Perform PK database lock
• Transform the relevant STDM and ADaM datasets, and other sources of data to enable PPK, PKPD and ER analyses
• Develop SAS (or R) codes to perform data visualization, descriptive statistical summary in TLFs
• Ensure dataset formatted according to CDISC standard
• Collaborate with biostatistics programmers, statisticians, and pharmacometricians, to ensure data consistency and accuracy for general PK, PK / PD and ER analyses
• Stay informed with the emerging literature in programming approaches in PMx field
• Maintain current understanding of global regulatory expectations for CDISC requirements

Requirements