Senior Statistical Programmer

Job Title: Senior Statistical Programmer

Employment Type: 12 months Contract (Extendable as needed).

Location: Anywhere in Taiwan

Experience: 3-8 Years

Primary Responsibilities:

Produces statistical analysis using SAS/R according to relevant standard operating procedures. Ensuring compliance to SOPs.

Programming analysis dataset without a 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 time frame

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.

Secondary Responsibilities:

Behavioral Competencies and Skills

Professional

Intellectual capability

Trustworthy

Action Orientation

Personal Growth

Prioritization

Quality focused

Active Listening

Personability

Willingness to learn

Team Player

Stress Management

Learning Agility

Result Driven

Timely Feedback

Candidate Profile

Bachelors degree or equivalent required, preferably in life science, statistics, computer science, or related subjects.

Should have a minimum of 3+ years of experience 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.