Technical Lead Statistical programmer

Ephicacy; India; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

A leading analytics company in India is seeking a Tech Lead for Statistical Programming with a focus on quality and timely execution of SDTM, ADaM, and TFL artifacts. The ideal candidate should have at least 6 years of experience in the statistical programming domain, proficient in SAS programming, and a deep understanding of clinical trial data standards. Responsibilities include leading programming activities, mentoring team members, and ensuring compliance with regulatory standards. This role offers opportunities for continuous improvement and professional development.

Qualifications

• Minimum 6 years of experience in the Statistical Programming domain.
• Proficient in SDTM, ADaM, and TLF.
• Exposure to clinical trials in at least one therapeutic area.

Responsibilities

• Responsible for quality and timely execution of SDTM, ADaM/TFL artifacts.
• Develop and review specifications and create/validate SAS programs.
• Support and supervise programming team towards resolving study/program related issues.

Skills

SDTM

ADaM

SAS programming

Clinical trial knowledge

Communication skills

Education

Graduate/ post-graduate degree in Statistics or Biostatistics or Mathematics or Computer Science or Pharmacy

Tools

SAS

Job description

Job Title:

Tech Lead – Statistical Programming

Department:

Clinical Analytics/Project Based Services

Job Responsibilities

Works on issues of limited scope. Follows established practices and procedures in analyzing situations or data from which answers can be readily obtained. Work is reviewed upon completion and is consistent with departmental objectives.

• Primarily responsible for quality and timely execution of SDTM, ADaM /TFL artifacts (Annotated CRF, Specifications, Datasets, Define.xml etc.) for assigned studies
• Develop and review specifications (Defines) and create/validate SAS programs for the mapping of raw datasets to CDISC SDTM, ADaM standards.
• Develop, debug, and maintain simple to moderately complex programs, macros, and utilities
• Develop and/or validate SAS programs to generate SDTM, ADaM datasets and TLFs to ensure regulatory compliance
• Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members.
• Act as a primary point of contact for SDTM, ADaM/TFL programming activities
• Develop utility macros for reusability and efficiency
• Experience on e-submission packages like SDRG, ADRG, Define.xml
• Good Exposure on ISS and ISE
• Support & Supervise Programming team towards resolving study/program related issues and thereby efficiently meet all project timelines & deliver quality outputs.
• Mentor and evaluate team members to establish training and coaching needs.
• Assist in training for new resources and as a part of continuous improvement.
• Participate in study/project team meetings as a core member and provide technical expertise/support
• Provide programming input to CRF and External Data
• Compliance to regulatory requirements
• Commitment to compliance with Integrated management system which includes standards like ISO 9001, 27001, 22301 and any new standards that the organization plans to implement.
• Participate in the trainings organized for these applicable standards.

Qualifications & Certifications

Education Qualification

Graduate/ post-graduate degree or equivalent in Statistics or Biostatistics or Mathematics or Computer science Or Pharmacy

Professional Qualification

• Minimum 6 years of experience in Statistical programming Domain
• Proficient in SDTM/ADaM/TLF
• Exposure to work on clinical trials pertaining to at least one Therapeutic area would be preferrable