Principal Statistical Programmer

Jobtailor; Hyderabad; On-site; INR 1,500,000 - 2,600,000; Full time

Job summary

Jobtailor in Hyderabad seeks an experienced Senior Statistical Programmer to lead SAS programming for global clinical trials, develop SDTM/ADaM datasets, verify QA, and ensure regulatory compliance.

You will mentor junior programmers, design SAS macros, validate datasets, review SAP, and collaborate with Data Management, Clinical Operations, and project teams to deliver high-quality analyses on time.

Qualifications

• Bachelor’s degree in a relevant scientific field with 8+ years of experience or equivalent.
• Strong SAS/Base, SAS/Stat, SAS Macros, SAS/Graph expertise required.
• Deep knowledge of CDISC SDTM and ADaM data models and regulatory guidelines.

Responsibilities

• Provide statistical programming support for clinical trials, including datasets, tables, listings, and figures.
• Develop and validate SDTM mappings and companion datasets; ensure data integrity.
• Lead development of SAS macros and utilities to speed programming tasks.
• Review SAP and ensure alignment with programming deliverables.
• Mentor junior programmers and oversee training plans.
• Collaborate with Data Management, Clinical Operations, and PM for on-time delivery.

Skills

SAS programming

CDISC SDTM/ADaM knowledge

Analytical skills

Problem-solving

Independent work

Statistical programming

Data issues identification

Communication of technical concepts

Organization & time management

Regulatory guidelines familiarity

Leadership & mentoring

SAS certifications preferred

Education

Bachelor’s degree in computer science, statistics, or related field

8+ years of relevant professional experience

Tools

SAS Base Certification

SAS Advanced Certification

SAS Clinical Trials Certification

Job description

Responsibilities

• Provide statistical programming support to clinical trials, including generating/validating analysis datasets, tables, listings, and figures; create SDTM mapping and datasets; develop and maintain the infrastructure for project files of SAS datasets and code; support Data Management with dataset creation, transfers, integrity checks, and quality audits; act as a liaison between clinical and subcommittees and project teams as needed.
• Perform or oversee the team in performing all statistical programming required for clinical trial analysis and reporting on large‑scale projects of high complexity.
• 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 and development of SAS macros and other utilities to expedite SAS programming activities.
• Organize and conduct internal training sessions and author papers for conferences.
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client requests.
• 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 reviewers guide and analysis datasets reviewers 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 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 and 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.
• Contribute to the development of standard operating procedures for statistical programming.
• Adhere to all aspects of the SDC’s quality system.
• Comply with SDC’s data integrity and business ethics requirements.
• Perform other related duties incidental to the work described herein.
• Maintain adherence to all essential systems and processes required at SDC to maintain compliance with business and regulatory requirements.

Qualifications

• 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, SAS Macros, and SAS/Graph.
• Strong problem‑solving skills.
• Ability to work independently.
• Excellent knowledge of statistical programming.
• Proficiency in manipulating and analyzing SAS data.
• Ability to identify data issues, present problems, and implement solutions quickly.
• Capability of communicating technical concepts clearly, concisely, and understandably to non‑statistical colleagues.
• Good organizational and time‑management skills, with the ability to multi‑task.
• 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.
• Very strong interpersonal communication, presentation, and leadership skills.
• SAS Base, Advanced and Clinical Trials Certification is preferred.
• Education or Equivalent Experience:
• Bachelor’s degree in computer science, statistics, or another related scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience.

Core Competencies

Demonstrates strong SAS programming expertise, including SAS/Base, SAS/Stat, SAS Macros, and SAS/Graph, while applying statistical methods for clinical trial data analysis. Possesses a deep understanding of CDISC SDTM and ADaM data models, ensuring compliance with regulatory guidelines and quality standards.