Director, Statistical Programming - Team Build

$200k - $230k

Full-time

Astera Search

Role Description

A well-established, secure and commercially active biopharma is building out its US statistical programming team. This is a hands-on leadership role that will oversee the build-out of a fully in-house function.

Lead the statistical programming function for the oncology portfolio
Build and develop the new US statistical programming team
Define programming strategy, standards, and processes
Oversee in-house development and validation of SDTM, ADaM datasets, and TFLs
Support regulatory interactions, including IND, NDA/BLA submissions
Collaborate with Biostatistics, Clinical Data Management, and Regulatory on submission readiness

Qualifications

Bachelor's or Master's degree in a relevant discipline
Extensive SAS programming experience within pharma or biopharma; oncology background required
Demonstrable experience working directly for a sponsor company
Strong knowledge of CDISC standards (SDTM, ADaM) and FDA/EMA submission requirements
Proven leadership of a programming team or function
East Coast based only

Requirements

Compensation DOE - $200,000 - $230,000 base salary + benefits

Apply

Vacancy posted 20 hours ago

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