Associate Director, 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
• Provides statistical programming expertise within Biogen, including demonstrated proficiency in CDISC SDTM (Study Data Tabulation Model) and CDISC ADaM (Analysis Dataset model) implementation.
• Authors analysis data set specifications including the identification of potential data issues or areas of critical data examination.
• Engages with Biostatistics to define and document programming endpoint 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 in SSM to ensure compliance to eSUB standards
• Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT
• Serves as the Statistical Programming Lead to achieve milestones for an indication of a drug program/Therapeutic Area; 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
• Aligns internal and external project team members on statistical programming requirements, deliverable status, and resource needs

Requirements

• BA/BS
• 12 years relevant work experience within an organization with a focus on data management and analysis
• 12+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
• 12+ years relevant industry experience
• 12+ years clinical trial experience
• 10+ 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
• Strong management skills, and ability to effectively lead and collaborate with all functions
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience with R is a plus

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