Senior Stat/Pr Stat Programmer, PKPD Programming

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

🖥 Softwareentwickler

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Syneos Health

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10.000+ Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health ist eine führende, vollständig integrierte biopharmazeutische Lösungsorganisation, die darauf ausgelegt ist, den Erfolg ihrer Kunden zu beschleunigen. Sie übersetzen einzigartige klinische, medizinische und kommerzielle Erkenntnisse in Ergebnisse, um den Anforderungen des modernen Marktes gerecht zu werden. Durch die Nutzung fortschrittlicher Technologien und Erkenntnisse arbeitet Syneos Health mit Kunden zusammen, um die Bereitstellung wichtiger Therapien für Patienten weltweit zu beschleunigen, und bietet Dienstleistungen, die das gesamte Spektrum von der klinischen Entwicklung bis zur Kommerzialisierung abdecken.

Beschreibung

• 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).

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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.