Role: Statistical Programmer

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

Salary Range: 11 - 20 LPA

Shift: General Shift

Location: 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.