[Hiring] Pr Statistical Programmer @Syneos Health

Role Description

The Statistical Programmer (ADAM, TLF, SDTM) at Syneos Health is responsible for the following:

• 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.
• Performs validation programming and collaborates with other programmers, biostatisticians, and project team members to resolve discrepancies or findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows 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, sets goals based on priorities from management, and adapts to timeline or priority changes.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
• Anticipates and addresses potential programming issues, establishes the basis for efficient programming, and accurately defines all variables for peer review and sponsor/requestor.
• Conducts effective internal meetings, distributes relevant information in advance, and ensures minutes are promptly and accurately distributed.
• Displays willingness to work with others and assist with projects and initiatives as necessary.
• Accountable for on-time delivery across concurrent programming deliverables and negotiates programming timelines.
• Acts as the lead statistical programmer, directing the programming activities of other personnel.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, and SAS database design.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative.
• Contributes to mentoring programming personnel through developing training courses and providing feedback.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements.
• Works cooperatively with other biostatistics and statistical programming personnel to establish SOPs, guidelines, and policies.
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• Provides guidance and training on the appropriate use of CDISC Standards.
• Performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications.
• Actively participates in industry standards organizations and provides updates to the Biometrics Department.
• Transfers deliverables and performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

• 8+ years of experience in Clinical SAS Programming.
• Strong expertise in Base SAS/SAS Macros, SDTM, ADAM & TLF programming, and specs creation.
• Hands-on experience with both Safety & Efficacy data.
• Preferred experience in Oncology therapeutic areas.
• ISS/ISE experience and R programming skills are preferred.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.
• Immediate joiners are preferred.

Benefits

• 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.
• Opportunity to shape solutions that impact lives.
• Collaborative environment with smart colleagues from across the world.

Company Description

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.