Sr Statistical Programmer(ADaM & TLF)

Syneos Health; Hyderabad; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Syneos Health is seeking an experienced Statistical Programmer to develop SAS code for tables, listings, graphs, and derived datasets in a clinical trial setting.

You will ensure quality outputs, validate programming, and coordinate with statisticians and team members. Leadership of programming activities and mentoring are included, with limited travel.

Qualifications

• Undergraduate degree in a scientific or statistical discipline; equivalent combination accepted.
• 5+ years SAS Programming experience in a clinical trial environment.
• Strong experience in CDISC-ADAM & TLF generation; submission activities a plus.

Responsibilities

• Develops custom programming code using SAS to generate summary tables, listings, graphs and derived datasets per SAP and specs.
• Ensures outputs meet quality standards and project requirements; performs validation and resolves discrepancies with team.
• Maintains organized documentation and QC/verification to ensure inspection readiness.
• Leads programming activities, sets goals, and estimates timelines across multiple projects.
• Participates in sponsor meetings and mentors junior programmers as needed.
• Minimal travel may be required.

Skills

Communication

SAS programming

Clinical trial knowledge

Education

Undergraduate degree in science/ statistics

Tools

Base SAS

Advanced SAS / SAS Macros

CDISC ADaM & TLF

Job description

Role & responsibilities

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.
• Require 5+ years of experience in SAS Programming or other required software, preferably in a clinical trial environment.
• Must have strong experience in CDISC- ADAM & TLF generation.
• Good to have experience of submission activities.
• Must have strong experience in Base SAS, Advance SAS/ SAS Macros.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

Email:[e-mail]