Associate Director, Safety Analytics

About the position

The Associate Director Safety Analytics will be responsible for ensuring the Safety & Regulatory Operations, Medical Writing and Benefit Risk Management (SABR) organization utilizes technology and process optimization to identify and implement opportunities to meet business objectives. They will provide insight to SABR to solve problems with technology and process improvements and ensure consistency in design and implementation of solutions. The Associate Director will be responsible for collaborating and implementing initiatives to achieve these goals.

Responsibilities

• Provide expertise supporting reporting environment move to Snowflake architecture (including database design and build, reports/analyses migration and development, and validation strategy).
• Provide technical leadership and partnership with IT on large scale software implementations supporting Pharmacovigilance and Regulatory teams.
• Develop and implement SABR technology strategy and prioritization to support Biogen initiatives.
• Provide best practices across technology platforms to ensure a single TADI approach for system utilization, application/solution development, reporting and visualizations.
• Identify and provide best implementation practices for new technologies (e.g., Oracle Apex, Python for extracting case narratives, evaluation AWS toolsets, API programming, etc.).
• Understand and optimize use of current technology to identify and solve complex business problems (e.g., data collection tools using low code development, integration across multiple platforms, etc.).

Requirements

• Advanced experience working with drug safety reporting databases (ArisG, Argus, Veeva, etc.) including API programming and database design.
• Practical experience developing applications using low code development tools (e.g., Oracle Apex, Appian).
• Knowledge of Artificial Intelligence (including Robotic Process Automation, Machine Learning, LLM, NLP) and business/process implications.
• Expert database programming knowledge (Snowflake, Oracle) including SQL, pl/SQL, Python.

Nice-to-haves

• Knowledge of Regulatory Tracking, Submission, and Publishing tools (e.g., Veeva, Lorenz, ArisG).
• Working knowledge of SAS.

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 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.