Job Title: Tech Lead Statistical Programming
Department: Clinical Analytics/Project Based Services
Location: Bangalore, Remote, India
Knowledge and Application:
Receives predetermined work assignments that are process-driven and subject to a moderate level of control and review. Provides guidance to junior resources on a course of action based on knowledge of established policies and procedures.
- Profound knowledge of the reporting process
- Experience in developing standard macros and modifying them for study requirements
- Analyst mindset (planning, execution, problem solving skill)
- Excellent attention to detail
- Understanding of the Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents.
- Well conversant with regulatory requirements and drug development process. Understand and comply with ICH-GCP guidelines and Code of Federal Regulations (CFR). Adept with quality policies and guidelines as recommended by USFDA, EU, WHO, and ANVISA thereby keeping abreast with the current regulations.
- Good understanding of Clinical trial domain.
- Proactive with communication and adaptable in approach while working independently
- Ability to mentor/guide junior programmers and successfully taking care of small deliverables.
- Experienced in using SAS computing package, SAS Enterprise Guide, SAS VA, SAS DI, SAS ODS and Macros
- Good knowledge of CDISC standards
- Experience in migration of one SAS code from system to another system
- Excellent knowledge in SQL DDL, DML, Indexes.
- Macro Code Debugging capabilities
- Compliance to regulatory requirements
Key Responsibilities and Authorities
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
- 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.
Business Impact
Multiple Incumbent position. Moderate to nominal Impact On projects
Collaboration & Interaction
- Networks with key contacts outside own area of expertise.
- Adapts style and uses persuasion in delivering messages that relate to the wider firm business. Frequently advises others on complex matters.
- May be accountable through team for delivery of tactical business targets.
Span of control / supervision
- No direct reportees as such but at times might be involved in mentoring junior level resources.
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
Experience
6.1 8 Years
