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Senior Stat/Pr Stat Programmer, PKPD Programming
Syneos HealthSr Stat/ Pr Stat Programmer for Syneos Health utilizing SAS to develop and validate PK analysis datasets. Collaborating with clinical teams and ensuring high-quality programming output.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SASRprogrammingvalidation programmingdata analysisstatistical analysisdataset specificationsquality controlPK analysisCDISC
Soft Skills
communicationteam collaborationproblem-solvingtime managementorganizational skillsadaptabilitymeeting facilitationattention to detailgoal settingforethought