Senior Statistical Programmer

Job Description

Role: Senior Statistical Programmer

Location: Hyderabad

Experience: Minimum 6 years as Clinical Statistical Programmer

We are looking for Senior Statistical Programmer who is responsible for designing, developing, and implementing complex statistical programming solutions to support clinical trial data analysis. This role involves collaboration with cross-functional teams, including Biostatistics, Clinical Data Management, and Regulatory Affairs, to ensure high-quality and timely data deliverables. The Senior Statistical Programmer is expected to handle programming activities for clinical studies and may provide guidance to junior programmers.

Key Responsibilities

• Act as programming lead on Phase I-IV group of studies.
• Leading the studies and acting as the POC for multiple studies.
• Perform programming activities for a trail indication.
• Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with SDTM Implementation Guide, project standards, and the study protocol.
• Perform CDISC activities in accordance with corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other regulatory requirements.
• Develop/Validate SAS analysis datasets (ADaM) and prepare tables, listings, and figures as per specifications, SAP and Mockshell.
• Creates programs to prepare graphs and tables that are required in clinical study reports, safety reports, efficacy reports, etc., ensuring on-time quality delivery.
• Perform CRF annotation and Specification creation as per CDISC standards.
• Validate tables, listings, and figures as per client required Mockshells.
• Supporting database QC activities.
• Support client and internal audits.
• Validate and transform datasets as per client specifications.
• Validate tables, listings, and figures as per client required specifications.
• Ability to work on data migration from legacy datasets to standards such as CDISC and client specific requirements.
• Communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
• Co-ordinate with the client regarding data issues, outliers, reviews, etc.
• Provide CDISC training, guidance, and project leadership to team members.

Education & Qualification

• M.Sc. Statistics, Bachelor's/Master's degree in Life Sciences, B. Tech (Any stream) and
• B. Pharmacy/M. Pharmacy

Skills

Strong written and oral communication skills and time management skills

Ability to effectively prioritize and execute tasks in a high-pressure environment.

Ability to work independently, take initiative and complete tasks to deadlines.

Ability to work in a team-oriented, collaborative environment.

Ability to work positively within a continually changing environment.

To be determined in achieving goals

Ability to manage multiple projects under tight timelines

Knowledge & Experience

Strong knowledge of global clinical trial practices, procedures, developmentprocess, and clinical trial data flow

Knowledge in TLF's

Knowledge in Data Analysis using SAS

Knowledge in Generating DEFINE.XML and Reviewers Guides for regulatory submissions.