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Senior Statistical Programmer, R/RShiny
Syneos HealthSenior Statistical Programmer utilizing R/RShiny to generate data analyses for life sciences applications. Collaborating with teams to ensure quality standards and regulatory compliance in statistical analysis.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
RRShinystatistical programmingCDISC programmingSDTMADaMdata analysis techniquesprogramming specificationsvalidation programmingquality control
Soft Skills
problem-solvinganalytical skillscommunication skillsinterpersonal skillsteamworkleadershiptime managementadaptabilitymentoringmeeting facilitation
Tools & Technologies
SASclinical trial softwareproject documentation toolsstatistical analysis softwaredata visualization toolsquality assurance toolsproject management softwareregulatory compliance toolsdata management systemsbiomarker analysis tools
Certifications & Qualifications
SAS Certified Advanced Programmer for SAS 9
Industry Keywords
clinical trialspharmaceutical settingbiostatisticsICH guidelinesSOPsWIsstatistical analysis planmock shellsannotated CRFsstudy programming activities
About the role
Key responsibilities & impact- Uses R/RShiny 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
- Minimal travel may be required
Requirements
What you’ll need- Advanced degree in Statistics, Computer Science, or a related field
- Extensive experience in statistical programming in a clinical or pharmaceutical setting
- Experience with CDISC programming (SDTM, ADaM)
- Experience with clinical trials and biomarker analyses
- Proficiency in the following programming languages: R and RShiny
- Strong understanding of statistical methods and data analysis techniques
- Excellent problem-solving and analytical skills
- Ability to work independently and as part of a team
- Strong communication and interpersonal skills
- Certifications SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred
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
- Commitment to building an inclusive culture