Uses SAS or other software 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 Statistical 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.
Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
May develop specifications for datasets and outputs according to statistical and Sponsor requirements.
Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, 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.
Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management.
May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables.
Assists with the transfer of deliverables.
Performs other work-related duties as assigned.
Minimal travel may be required.
Requirements
Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience.
Proficiency in programming in SAS or other required software, preferably in a clinical trial environment.
Require Statistical Programmer II (2-4yrs); Sr Statistical Programmer (5-8yrs); Principal Stat Programmer (8yrs above) relevant experience in Clinical SAS
SAS/SQL, R programming skills
Hand on experience in Anonymization of Clinical Datasets will be given weightage
Experience in Github / GitLab preferred
SDTM / ADaM Theoretical knowledge and SDTM hands on experience will be value added.
Excellent written and verbal communications skills.
Capable Programmer(s) with proven R (R Studio) skills.
SQL experience will be useful to write conditions for data redactions.
Some knowledge of Python may be useful e.g. to look at code / outputs.
Good eye for detail to review clinical data pre - and post-processing from the anonymization ruleset tool.
Knowledge of the drug development process (Phase I through IV) and general regulatory requirements.
Study lead experience and capable of managing multiple studies.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Benefits
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 our Total Self culture – where you can authentically be yourself.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SASSQLR programmingAnonymization of Clinical DatasetsSDTMADaMGitHubGitLabPythonStatistical analysis
Soft skills
excellent written communicationexcellent verbal communicationattention to detailteam collaborationproject managementproblem-solvingadaptabilitygoal settingtime managementleadership