Lead Statistical Programmer - SAS/R, CDISC, Regulatory

REALIGN LLC; Cincinnati (OH); On-site; USD 110,000 - 160,000; Full time

Job summary

REALIGN LLC seeks a Lead Statistical Analyst to oversee statistical programming for a compound/indication in Cincinnati, OH. You will lead a team of programmers, ensure timely, compliant analyses and create ADaM datasets per CDISC standards.

The role involves mentoring staff, developing SAS scripts for TLFs and figures, and coordinating regulatory submission documentation within a cross-functional team.

Qualifications

• Experience leading a team of statistical programmers for a compound/indication or therapeutic area.
• Proficiency in SAS / R for ADaM, TFL and statistical analyses.
• Deep understanding of SAS concepts in drug development and study life cycle.
• Experience with CDISC standards and multiple therapeutic areas.
• Experience with regulatory filings.

Responsibilities

• Lead statistical programming activities for a compound/indication.
• Manage a team of statistical programmers and resource planning.
• Ensure timely deliverables and adherence to quality processes.
• Develop SAS programs for ADaM datasets per CDISC standards.
• Develop SAS programs for Tables, Listings and Figures.
• Ensure consistency of ADaM datasets across studies.
• Create documentation for regulatory filings and data definitions.
• Lead development of standard SAS Macros and SOPs.
• Provide mentoring of staff across levels.

Skills

Team leadership

SAS programming

R programming

CDISC standards

Regulatory filings

Communication skills

Cross-functional collaboration

Effort estimation

Deadline management

Tools

SAS

R

Job description

REALIGN LLC seeks a Lead Statistical Analyst to oversee statistical programming for a compound/indication in Cincinnati, OH. You will lead a team of programmers, ensure timely, compliant analyses and create ADaM datasets per CDISC standards.

The role involves mentoring staff, developing SAS scripts for TLFs and figures, and coordinating regulatory submission documentation within a cross-functional team.