Principal Statistical Programmer, SDTM

🕒 vor 11 Tagen

🇺🇸 Vereinigte Staaten – Remote

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🔴 Experte

🖥 Softwareentwickler

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Syneos Health

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10.000+ Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

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). • Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. • Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Transfers deliverables. • Performs other work-related duties as assigned.

🎯 Anforderungen

• Undergraduate degree, preferably in a scientific or statistical discipline; • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English.

🏖️ 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. • Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We’re a growing, global company dedicated to advancing our talent past their initial role.