Statistical Programmer

3 days ago

Mumbai Metropolitan Region, India StaffLink Express Full time ₹ 5,00,000 - ₹ 10,00,000 per year

Role: Statistical Programmer

Job Code: 357890

Band: BPO 4/5/6 for locations: Mumbai/Pune/Bangalore

Salary Range: LPA

Shift: General Shift

Location: Mumbai/Pune/Bangalore

**CV must be rejected if candidate is not in Mumbai / Pune / Bangalore**

Preferred Educational Qualification for the role: Life science graduate / Computer science graduate/ Statistical graduate

Preferred experience for the role: Minimum 2+ years of experience in SAS programming

Reporting to (Role): Delivery Manager

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/indication.


• 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.

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