Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
Authors CDISC (Clinical Data Interchange Standards Consortium) ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination.
Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
Manages the end-to-end programming of deliverables from CRF (Case Report Form) collections through electronic submission including preparation of electronic submissions components; works with SMEs (Subject Matter Expert) to ensure compliance to submission standards.
Serves as the Statistical Programming Lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.
Verifies program consistency and usage of data, analysis and submission standards within a study in consultation with data standards, statistical submissions management and the data strategy plan.
Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
7+ years relevant work experience within an organization with a focus on data management and analysis
7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
7+ years relevant industry experience
7+ years clinical trial experience
5+ years clinical database experience
CDISC and/or submissions experience
Knowledge of drug development process and clinical trials
Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
Familiarity with AI and ML concepts

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short
and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

Principal Analyst, Statistical Programming

Key skills