Principal Statistical Programmer (SDTM)

Syneos Health; India; On-site; INR 1,500,000 - 3,500,000; Full time

Job summary

Syneos Health, Inc. is seeking a Principal Statistical Programmer (SDTM) to develop SAS-based programming for tables, listings, graphs, and derived datasets per the SAP. The role collaborates with biostatistics and project teams to ensure quality and regulatory compliance.

The candidate will lead programming activities across multiple studies, maintain documentation, and participate in sponsor meetings while managing timelines and resource needs. Some travel may be required.

Qualifications

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.

Responsibilities

• Uses SAS or other software to develop programming code for tables, listings, graphs, and derived datasets per the SAP and programming specifications.
• Ensures outputs meet quality standards and project requirements.
• Performs validation programming and collaborates with programmers, biostatisticians, and project team members to resolve discrepancies.
• Maintains organized, up-to-date project documentation, testing, and verification/quality control documents and programs.
• Manages scheduling and time constraints across multiple projects, develops dataset specifications, and adapts to changes in timeline or priority.
• Participates in sponsor meetings and mentoring of programming personnel; transfers deliverables.
• Acts as lead statistical programmer; directs programming activities of other programmers and reviews project documentation.
• Performs other work-related duties as assigned; minimal travel may be required.

Skills

SAS

SDTM

Clinical programming

Education

Bachelor's degree in Statistics or related field

Tools

SAS Studio

SAS EG

Job description

Principal Statistical Programmer (SDTM)

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:

• 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

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.

Minimal travel may be required.

Qualifications

Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.