Senior Statistical Programmer, SDTM, ADaM, TLF

🕒 September 25

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 33%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets • Ensure outputs meet quality standards and project requirements • Perform validation programming and resolve discrepancies with Programmers, Biostatisticians, and project team members • Keep project team members informed of programming progress and issues • Follow applicable SOPs, WIs, and regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, quality-control documents, and programs • Manage scheduling and time constraints across multiple projects • Develop specifications for datasets and outputs of varying complexity • Anticipate and address programming issues and define variables for peer review and sponsor/requestor approval • Prepare for and conduct internal meetings, distribute information and minutes, and follow action items to completion • Estimate and complete study programming activities within allotted timelines • Act as lead statistical programmer and direct other programming personnel • Monitor progress on programming deliverables • Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs • Participate in sponsor, kickoff, and bid defense meetings as the statistical programming representative • Mentor programming personnel through training, work review, feedback, and guidance • Transfer deliverables and perform other assigned duties

🎯 Requirements

• 5-8 years of experience • End-to-end programming experience • Strong hands-on expertise in SDTM, ADaM, and TLF development • Exposure to efficacy endpoints and analyses • Basic understanding or training in R Programming • Experience in Oncology • 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 • Graduate degree, preferably in a scientific or statistical discipline; an equivalent combination of education and demonstrated programming experience may be considered • Immediate joiners are preferred

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Minimal travel may be required

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