Associate Director, Safety Analytics

Posted Yesterday
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Durham, NC
163K-225K Annually
Senior level
Biotech
The Role
The Associate Director Safety Analytics oversees technology optimization in medical writing and regulatory operations, implements technology strategies, and collaborates to enhance business processes.
Summary Generated by Built In

Job Description

About This Role

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.  

What You’ll Do

  • 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.).

 

Who You Are

You are passionate about optimizing systems, processes, and data to drive key business decisions. You love learning and applying new technologies to solve business problems.

 

Qualifications

Required Skills

  • 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

Preferred Skills

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

Additional Information

The base salary range for this position is $163,000 - $225,000. Base salary offered is determined though an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.  Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.   

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:  

  • 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   

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

 

Top Skills

Api Programming
AWS
Llm
Machine Learning
Nlp
Oracle Apex
Pl/Sql
Python
Robotic Process Automation
Snowflake
SQL
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The Company
HQ: Cambridge, MA
9,575 Employees
On-site Workplace

What We Do

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.

Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.

With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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