Senior Principal Analyst, Statistical Programming

Role Overview

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight.
• Considered a statistical programming expert within the department.
• Authors CDISC 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.
• Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs), works with SMEs to ensure compliance to eSUB standards.
• Identifies process inefficiencies and leads efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON.
• Serves as the Statistical Programming Lead to achieve milestones for a drug program; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs.
• Verifies program consistency and usage of data, analysis and submission standards across the department 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.

Requirements

• Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred.
• 10 years relevant work experience within an organization with a focus on data management and analysis.
• 10+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO.
• 10+ years relevant industry experience.
• 10+ years clinical trial experience.
• 5+ years clinical database experience.
• CDISC and/or submissions experience.
• Extensive knowledge of drug development process and clinical trials.
• Extensive 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 AI and ML concepts.

Tech Stack

• Unix

Benefits

• 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