Description

• This role reports to the Manager, Statistical Programming, and above
• Produces complex statistical analysis using SAS/R according to relevant standard operating procedures.
• Ensuring compliance to SOPs and internal process for the project managed
• Programming analysis dataset without specifications and review of SAS programs in the designated clinical trail
• Develop SDTM/ADaM specifications as per the company or client standards
• Ensure the project team delivers the projects within agreed timelines and quality standards. Ability to lead multiple studies (e.g., CSR, DMC, PSUR/DSUR, etc.)
• Developing SAS Programs for the complex statistical analysis of study data, including analysis of datasets, tables, listings, and figures
• Programming according to CDISC SDTM and ADaM datasets
• Review Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines
• Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines.
• Preparing and performing internal training on statistical programming processes and techniques. Support the less experienced team for technical issues
• Make certain that the study team ensures project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs
• Provide guidance, mentoring, and training for junior team members and help solve issues from cross-functional teams
• Represent ClinChoice/Department during internal and external audits
• Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group.
• Anticipate/identify the risk or issues within the project and proactively communicate to the trial lead or manager
• Actively present lesson learning/ best practices/ best approaches in knowledge-sharing meetings, ask questions, and share feedback continuously to improve the process or standards of the programming.

• Proactively communicate and collaborate with the global team by understanding the time zone differences.
• Support the resourcing manager for effective resource allocation and team utilization within the study budget
• Drive innovative solutions or projects to improve the process or programming methodologies or patterns or solutions.
• Conducts other statistical programming activities as required
• Conduct other administrative and departmental activities as needed.

Requirements

• Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects

Years of Experience

• At least 3 years of experience within the pharmaceutical industry with clinical programming and clinical development processes across therapeutic areas.

Skills

• Comprehensive knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis of the requirements for clinical programming projects.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
• Excellent written and verbal communication skills, collaboration, and interpersonal skills.
• Strong experience in ADaM programming (Development and Validation)
• Strong experience in TLF programming (Development and Validation)
• Strong experience in SAS Programming
• Good Knowledge or Strong Experience in SAS Macro Programming.
• It is preferable to have R/Python experience (Not a mandatory requirement)