Senior Stat/Pr Stat Programmer, PKPD Programming

Job Description:

• Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements.
• Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts effective internal meetings (appropriate in format, frequency and attendance).

Requirements:

• A B.Sc (or equivalent) in Mathematics, Statistics, Computer Science or related subject with 5+ years of experience in clinical domain.
• Intermediate to advanced programming skills in R.
• Strong CDISC domain knowledge, PK workflows of various study designs and implementation.
• Develop and validate PK analysis datasets and displays(e.g., such as ADPC, ADNCA, ADPP and corresponding displays).
• Generate tables, listings, and figures (TLFs) for PK analysis and reporting.
• Partner with Clinical Pharmacologists, Statisticians, and Study Lead Programmers to understand analysis requirements and translate them into effective implementation programmatically.
• Act as subject matter expert (SME) for PK analysis programming.
• Communicates complex PK and analytical concepts clearly and concisely, ensuring.

Benefits:

• We are passionate about developing our people, through career development and progression;
• supportive and engaged line management;
• technical and therapeutic area training;
• peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.