Lead Statistical Analyst-5

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

Required Skills

• Experience in leading a team of statistical programmers for a compound/indication or therapeutic area
• Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
• In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle
• Good to have experience in other statistical programming languages (R).
• In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)
• Experience with regulatory filings.
• Effective communication skills (both written and verbal)
• Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations).
• Ability to accurately estimate effort required for project related programming activities.
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines

Job Type: Full Time

Job Category: IT

Job Description

Role – Lead Statistical Analyst

Location – Cincinnati, OH

FTE

Key Responsibilities

• Leads the statistical programming activities for a compound/inidication.
• Leads a team of statistical programmers and manages the resource planning for assigned staff.
• Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
• Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
• Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
• Ensures consistency of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers guides and data definition documents.
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.