Principal Statistical Programmer (SDTM)

Syneos Health, Inc.

India

Remote

INR 1,800,000 - 2,800,000

Full time

3 days ago
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Job summary

Syneos Health, Inc. is seeking a Principal Statistical Programmer (SDTM) for a remote, India-based role. You will develop and validate SDTM datasets, create listings, tables, and graphs according to the SAP and specifications, while ensuring compliance with ICH guidelines.

You will lead programming deliverables, mentor junior programmers, manage timelines across projects, and collaborate with Biostatistics teams to drive high-quality results in a fast-paced environment.

Qualifications

  • Extensive programming experience in SAS in a clinical trial environment.
  • Excellent written and verbal communication skills.
  • Proficient in English.

Responsibilities

  • Develop and validate SDTM datasets, listings, and graphs per SAP and specs.
  • Ensure outputs meet quality standards and regulatory requirements.
  • Lead programming deliverables and coordinate with Biostatistics teams.
  • Maintain project documentation and timelines across multiple studies.
  • Mentor junior programmers and contribute to training.

Skills

SAS programming
SDTM standards
Statistical analysis

Education

Bachelor's degree in statistics

Tools

SAS

Job description

Principal Statistical Programmer (SDTM)This website uses cookies to enhance user experience and to analyze performance and traffic on our website. We also share information about your use of our site with our social media, advertising and analytics partners. Privacy Notice# Work Here Matters Everywhere## Principal Statistical Programmer (SDTM)Apply: Remote (Pre-Approved): IND-Remote: Full time: Posted Today: End Date: November 30, 2026 (30+ days left to apply): 25114101Principal 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: 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*** 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.* Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.* Excellent written and verbal communication skills.* Ability to read, write, speak and understand English.
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