Senior Principal Statistical Programmer

Senior Principal Statistical Programmer

The Senior Principal Statistical Programmer serves as the technical architect for complex clinical projects. You will not only lead the execution of programming tasks but also define the strategies and standards that ensure clinical trial data is submission-ready, high-quality, and compliant with global regulatory requirements.

Responsibilities

• Oversee the creation of CDISC compliant submission readiness output including but not limited to datasets (SDTM, ADaM), Tables, Listings and Figures (TFLs) and associated Define packages.
• Serve as the technical lead and primary programming point-of-contact for external CROs and vendors.
• Review study materials, including CRF, SAP/shells, specifications and provide technical guidance both internally and externally.
• Collaborate with cross-functional teams to ensure accurate translation of statistical analysis plans (SAPs) into deliverables
• Support all in-house programming activities, if needed, including but not limited to regulatory filings, adhoc analysis, publication requests etc.
• Contribute to process improvement or initiatives to increase team efficiency and quality.

Qualifications

• Bachelor's or Master's degree in Statistics, Computer Science, Life Sciences, or a related field.
• 7+ years of SAS programming experience in the biotech/pharma industry
• Experience working with and managing external CROs or FSPs for programming deliverables.
• Solid knowledge with CDISC (SDTM/ADaM) standards and extensive programming experience with SAS Base, Macro, SQL, and Graph; working knowledge of R is a plus.
• Familiar with data pooling to support integrated summary of Safety (ISS) / Efficacy (ISE).
• Excellent communication skills and ability to work cross-functionally in a team environment.
• Demonstrated ability to handle multiple priorities with timelines.

Compensation

The expected base salary range for this position is $116,156 to $150,852. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page. Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.