Sr Statistical Programmer (NA Only)

Syneos Health, Inc.; New York (NY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Syneos Health is seeking an experienced Lead Statistical Programmer to contribute to a full spectrum of programming activities within the Clinical Solutions team. The role focuses on developing summary tables, data listings, graphs, and derived datasets per the statistical analysis plan, using SAS and other tools.

You will lead programming efforts across multiple projects, ensuring quality, adherence to SOPs/ICH guidelines, and timely delivery while mentoring junior staff and coordinating with

Qualifications

• Must be in North America to be considered.

Responsibilities

• 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 collaborates with other programmers, biostatisticians, and project team members to resolve discrepancies.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs and regulatory guidelines (ICH).
• Maintains organized project documentation, testing, and verification/quality control documents and programs for inspection readiness.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities, and adapts to timeline changes.
• Develops specifications for datasets and outputs according to sponsor requirements; anticipates issues and defines all variables for peer review with minimal rework.
• Prepares for internal meetings, contributes ideas, and respects others' opinions.
• Conducts effective internal meetings, distributes information, and follows up on action items.
• Collaborates with others to meet business needs.
• Negotiates and establishes accurate time estimates for study programming activities and completes tasks within timelines.
• Acts as lead statistical programmer and guides other programmers.
• Reviews project documentation and provides feedback to reduce inefficiencies.
• Participates in sponsor meetings and kickoff meetings as statistical programming representative.
• Mentors programming personnel by developing training materials and guiding new associates.

Tools

SAS

Job description

Updated: Yesterday
Location: Remote, NY, United States
Job ID:25108972-OTHLOC-1500-2DNY-2DR

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.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• 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. Central to this is our purpose – 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 are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Must be in North America to be considered.

• 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 allvariables 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.