Senior Principal Statistical Programmer
Novartis
3 months ago
On-site
East Hanover, NJ
$119,700 - $222,300 USD yearly
Clinical Research and Development
Key Responsibilities:
- Lead statistical programming (SP) as a trial programmer (one or multiple trials) or as lead/program programmer (program or indication).
- Coordinate internal/external programmers; make SP decisions and propose study/program/disease-level strategies.
- Manage associates as needed (supervision, guidance on functional/operational expertise and processes).
- Partner with cross-functional teams; provide status updates on deliverables and critical programming aspects (timelines, scope, resource plan).
- Review eCRF and data structures; ensure program-level standardization for pooling and CRT (case record tabulation).
- Ensure compliance with standards/processes (e.g., CDISC); assess/clarify additional requirements; develop/influence programming specifications for analysis plans.
- Deliver and validate programming solutions for CSRs, regulatory submissions, safety reports, publications, post-marketing, and exploratory analyses.
- Perform quality control and ensure inspection readiness and reliability/accuracy of analysis results.
- Maintain advanced knowledge of SAS/R and industry standards (e.g., CDISC, eCTD, Define.xml); act as SME for programming process improvements.
Required Qualifications:
- BS in statistics, computer science, mathematics, life science (or equivalent) + 7+ years in a programming role (preferably clinical trials/pharma).
- Trial/Lead/Program Programmer experience; ability to coordinate teams and transfer knowledge.
- Expert SAS/R; validated deliverables; experience developing advanced MACROs.
- Advanced experience with statistical analysis plans and/or technical programming specifications.
- Advanced knowledge of CDISC data structures/standard programs; understanding of GCP and regulatory requirements.
- Strong global communication and negotiation skills.
Preferred:
- MS or Ph.D in relevant field.
Compensation/Benefits (if applicable): Salary expected $119,700–$222,300/year; performance cash incentive; potential annual equity; comprehensive US benefits and time off.
- Lead statistical programming (SP) as a trial programmer (one or multiple trials) or as lead/program programmer (program or indication).
- Coordinate internal/external programmers; make SP decisions and propose study/program/disease-level strategies.
- Manage associates as needed (supervision, guidance on functional/operational expertise and processes).
- Partner with cross-functional teams; provide status updates on deliverables and critical programming aspects (timelines, scope, resource plan).
- Review eCRF and data structures; ensure program-level standardization for pooling and CRT (case record tabulation).
- Ensure compliance with standards/processes (e.g., CDISC); assess/clarify additional requirements; develop/influence programming specifications for analysis plans.
- Deliver and validate programming solutions for CSRs, regulatory submissions, safety reports, publications, post-marketing, and exploratory analyses.
- Perform quality control and ensure inspection readiness and reliability/accuracy of analysis results.
- Maintain advanced knowledge of SAS/R and industry standards (e.g., CDISC, eCTD, Define.xml); act as SME for programming process improvements.
Required Qualifications:
- BS in statistics, computer science, mathematics, life science (or equivalent) + 7+ years in a programming role (preferably clinical trials/pharma).
- Trial/Lead/Program Programmer experience; ability to coordinate teams and transfer knowledge.
- Expert SAS/R; validated deliverables; experience developing advanced MACROs.
- Advanced experience with statistical analysis plans and/or technical programming specifications.
- Advanced knowledge of CDISC data structures/standard programs; understanding of GCP and regulatory requirements.
- Strong global communication and negotiation skills.
Preferred:
- MS or Ph.D in relevant field.
Compensation/Benefits (if applicable): Salary expected $119,700–$222,300/year; performance cash incentive; potential annual equity; comprehensive US benefits and time off.