Principle Statistical Programmer (ADaM & TLF, SDTM)

Syneos Health; India; On-site; INR 1,500,000 - 4,000,000; Full time

Job summary

Syneos Health, Inc. is seeking an experienced Clinical SAS Programmer to join our Biostatistics team in India. The role focuses on developing programming code to produce analysis outputs and ensuring regulatory-ready delivery.

You will collaborate with statisticians, ensure quality standards, and lead deliverables across multiple projects while mentoring junior staff and maintaining thorough documentation.

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 Safety & efficacy data; Oncology experience is a plus.
• Excellent written and verbal English communication.

Responsibilities

• Develop custom programming code to generate summary tables, data listings, graphs and derived datasets.
• Validate programming outputs to meet quality standards and project requirements.
• Collaborate with biostatisticians and other project team members to resolve discrepancies.
• Maintain project documentation and ensure inspection readiness.
• Lead programming activities and monitor progress on deliverables.
• Participate in sponsor meetings and provide training support as needed.
• Provide risk mitigation plans and communicate status of deliverables to management.
• Mentor junior programmers and contribute to SOPs and standard tools.

Skills

Communication skills

English proficiency

Tools

SAS

Base SAS

SAS Macros

SDTM

ADaM

TLF programming

R programming

Job description

• 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 or 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.
• 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.
• Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
• 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.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
• Performs other work-related duties as assigned.
• Minimal travel may be required

Qualifications:

• Require 8+ years of experience in Clinical SAS Programming.
• Require strong expertise of Base SAS/SAS Macros, SDTM, ADAM & TLF programming, specs creation.
• Must have hands on experience of Safety & efficacy data.
• Good to have experience of Oncology therapeutic areas.
• Must have ISS/ ISE experience, R programming
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.