Lead Statistical Analyst

Job description

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 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.

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 & amp; Training Reimbursement.

Time Off

Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance

Legal As sistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1 </div

Qualifications

BACHELOR OF COMPUTER SCIENCE