Senior Stat/Pr Stat Programmer, PKPD Programming

🕒 Maio 8

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• 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).

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.