Senior Statistical Programmer
- 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.
- 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.