Lead statistical programming activities for multiple clinical trials within a program or indication/disease area
Accountable for timely and quality development and validation of all statistical programming components
Responsible for audit readiness of all assigned programming deliverables
Coordinate activities of internal/external programmers
Make statistical programming decisions and propose strategies at program or indication/disease level
Develop scientific documentation for the program or indication/disease area in collaboration with Biostatistician(s)
Responsible for allocating resources within a program

Requirements

BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 6+ years in a programming or statistical role
3+ years experience in a line management or equivalent leadership experience
In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
Expert in SAS or R programming, including development and validation of deliverables within a Statistical Programming environment
Significant experience in contributing to statistical analysis plans and developing technical programming specifications
Advanced knowledge of industry standards, including CDISC standards
At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications

Benefits

Comprehensive benefits package that includes health, life, and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays, and other leaves
Performance-based cash incentive

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

SASR programmingstatistical programmingstatistical analysis planstechnical programming specificationsprogramming validationaudit readinessresource allocationclinical trials methodologyGood Clinical Practice (GCP)

Soft skills

leadershipcoordinationdecision makingcollaboration