Senior Statistical Programmer

Sdcclinical; Hyderabad; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Sdcclinical is seeking a Senior Statistical Programmer to provide statistical programming support for clinical trials. You will produce statistical analyses, create SDTM/ADaM datasets, and develop SAS code and macros to support project teams.

You will review SAPs, ensure CDISC compliance, mentor junior programmers, and collaborate with Data Management, Clin Ops, and pharmacovigilance to deliver timely, high-quality results.

Qualifications

• Strong SAS programming skills (SAS/Base, SAS/Stat, SAS Macros, SAS/Graph).
• Experience with SDTM/ADaM data models and CDISC standards.

Responsibilities

• Provide statistical programming support for clinical trial analysis and reporting.
• Lead development of SAS macros and utilities to speed programming activities.
• Develop and validate SDTM/ADaM datasets and define.xml, reviewer guides, and tables/listings/figures.
• Review SAPs and ensure CDISC and FDA guideline compliance.
• Mentor junior programmers and collaborate with Data Management, Clin Ops, and Project Management.

Skills

SAS programming

SAS Base

SAS Macro

SAS/Stat

SAS Graph

CDISC SDTM/ADaM

Clinical trials

Data analysis

Problem solving

Independent work

Education

Bachelor's degree in CS/Statistics or related field

Tools

SAS Base

SAS Advanced

SAS Macros

SAS Graph

SAS/Stat

Job description

Job Summary

Senior Statistical Programmer Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.

Responsibilities

• Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on medium to large scale projects
• Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams
• Review the Statistical Analysis Plan in preparation for programming the planned analyses
• Lead design/development of SAS macros and other utilities to expedite SAS programming activities
• Conduct internal training sessions and author papers for conferences
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
• Participate in statistical program validation and quality control activities
• Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets
• Review Pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
• Develop define.xml, study data reviewer's guide and analysis datasets reviewer's guide
• Identify study priorities and communicate effectively with project team and management
• Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours
• Manage statistical programming timelines, budgets, and client expectations
• Actively participate in study team meetings
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
• Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management
• Program data cleaning checks, as necessary, to assist Data Management's data cleaning activities
• Participate in installation/validation of statistical software packages throughout the software development lifecycle
• Develop and maintain the infrastructure for project files of SAS datasets and SAS code
• Mentor junior level statistical programmers by developing training plans and providing oversight of their work
• Ensure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirements
• Adhere to all aspects of the SDC's quality system
• Comply with SDC's data integrity business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

• Strong analytical skills, with the ability to process scientific and medical data.
• Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros. Basic understanding of SAS/Graph
• Strong problem-solving skills
• Able to work independently
• Excellent knowledge of statistical programming
• Proficient in manipulating and analyzing SAS data
• Ability to identify data issues, present problems, and implement solutions
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models
• SAS Base, Advance, and Clinical Trials Certification is preferred

Education or Equivalent Experience

Bachelor's degree in computer science, statistics or other related, scientific field and at least six years of relevant professional experience; or an equivalent combination of relevant education and/or experience.