Lead Statistical Analyst

Tata Consultancy Services; Cincinnati (OH); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Discretionary annual incentive

Comprehensive medical coverage

Parental leaves

401K plan

Training reimbursement

Job summary

Tata Consultancy Services in Cincinnati, OH is seeking a Statistical Programming Lead to oversee program development in a therapeutic area, manage a team of statistical programmers, and ensure timely, high-quality deliverables. The role requires leading SAS and R programming to develop ADaM datasets and Tables, Listings and Figures, adhering to CDISC standards and supporting regulatory filings.

Bachelor of Computer Science and prior leadership experience in clinical statistics preferred; strong

Qualifications

• Experience leading a team of statistical programmers.
• Proficiency in SAS/R to program ADaM, TFLs and analyses.
• Strong knowledge of CDISC ADaM standards and regulatory expectations.

Responsibilities

• Leads the statistical programming activities for a compound/indication.
• Manages resource planning and ensures timely deliverables.
• Develops SAS programs for ADaM datasets and Tables, Listings and Figures.
• Maintains regulatory documentation and SOPs.
• Mentors junior programmers and supports cross-functional teams.

Skills

Team leadership

SAS programming

R programming

CDISC standards

Regulatory filings

Communication

Cross-functional teamwork

Effort estimation

Deadline management

Education

Bachelor of Computer Science

Tools

SAS

R

Job description

Job Description

We are looking for a Statistical Programming Lead to oversee program development activities for compound/indication or therapeutic area, lead a team of statistical programmers, manage resource planning, ensure timely deliverables, and maintain quality processes.

Key Responsibilities

• Leads the statistical programming activities for a compound/indication.
• Leads a team of statistical programmers and manages 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.

Required Skillsets

• 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.

Qualifications

Bachelor of Computer Science

Salary Range

$130,000-150,000 a year

TCS Employee Benefits Summary

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.