Senior Principal Programmer

The role:

The Senior Principal Programmer will report into the VP, Biometrics and provide strategic and technical leadership for clinical programming activities across clinical development programs. This individual will oversee CRO programming deliverables, support global regulatory submissions, contribute to ongoing study monitoring, and collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, and external vendors to ensure high-quality, compliant, and timely delivery of clinical data outputs.

Key responsibilities:

• Oversee CRO programming activities, including SDTM, ADaM, TFLs, define.xml, reviewer’s guides, and other clinical study or submission deliverables.
• Review CRO programming plans, specifications, datasets, outputs, QC documentation, issue logs, and submission packages.
• Ensure programming deliverables are accurate, traceable, reproducible, and compliant with CDISC standards and FDA/EMA expectations.
• Serve as the internal programming lead for FDA, EMA, and other regulatory submissions, including support for health authority questions and ad hoc analyses.
• Support ongoing study monitoring by reviewing safety, efficacy, DMC, interim analysis, patient profile, and data review outputs prepared by the CRO.
• Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.
• Work closely with Biostatistics, Clinical Operations, Regulatory, Safety, Data Management, CROs, vendors, and external partners to align timelines, deliverables, standards, and responsibilities.
• Coordinate with alliance or development partners on programming-related deliverables, review comments, issue resolution, and submission-readiness activities.
• Track CRO performance, identify programming risks, resolve issues, and ensure timely delivery of high-quality outputs.
• Provide programming input into protocols, SAPs, data standards, TFL shells, DMC charters, submission plans, and regulatory response strategies.

Required experience & skills:

• At least 10 years of experience in clinical statistical programming in biotechnology/ pharmaceutical industry
• Strong expertise in SAS, CDISC SDTM/ADaM standards, TFLs, define.xml, SDRG, ADRG, and regulatory submission requirements
• Experience overseeing CRO programming deliverables and supporting FDA/EMA submissions
• Strong expertise in clinical trials, data management processes, database lock, interim analyses, DMC support, and regulatory responses
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and comfortable operating with lean internal resources and contributing hands-on as needed

Preferred experience & skills:

• Prior experience serving as programming lead or submission programming lead
• Experience overseeing multiple studies or programs in parallel
• Experience working with global CROs, vendors, and external development partners
• Ability to read/communicate in Chinese is helpful

Base Salary Range: $250K - $295K

This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering.