Description

Job Responsibilities:

• This role reports to the Associate Manager – Statistical Programming, and above.
• Produces statistical analysis using SAS/R according to relevant standard operating procedures.
• Ensuring compliance to SOPs.
• Programming analysis dataset without specifications.
• Delivers the assigned tasks and projects within agreed timelines and quality standards.
• Developing SAS Programs for the statistical analysis of study data, including analysis of datasets, tables, listings, and figures.
• Programming according to CDISC SDTM and ADaM datasets.
• 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
• Make certain, that indication or 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, 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.
• Reporting issues to the Project or Study leads or Supervisors in an appropriate timeframe.
• Responsible for continuous development of own skills according to Individual development plan.
• Actively present in knowledge-sharing meetings, ask questions, and share feedback to improve the process or standards of the programming continuously.
• Proactively communicate and collaborate with the global team by understanding the time zone differences.
• Conducts other statistical programming activities as required.
• Conduct other administrative and departmental activities as needed.

Requirements

Candidate Profile:

• Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects.
• Should have 2-7 years of experience in Statistical Programming within the pharmaceutical industry.
• Good experience within the pharmaceutical industry with clinical programming and clinical development processes of across therapeutic areas.
• Good 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 the requirements for clinical programming projects.
• Good 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.
• Good written and verbal communication skills, collaborations, and interpersonal skills.