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Associate Director, Safety Analytics

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.

 

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Average salary estimate

$194000 / YEARLY (est.)
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$163000K
$225000K

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What You Should Know About Associate Director, Safety Analytics, Biogen

At Biogen, we’re excited to welcome an Associate Director, Safety Analytics to our team in Durham, NC! This role is all about leveraging technology and optimizing processes to support our Safety & Regulatory Operations, Medical Writing, and Benefit Risk Management (SABR) organization. You will play a key role by providing your expertise in moving our reporting environment to a Snowflake architecture while collaborating on large-scale software implementations to empower our Pharmacovigilance and Regulatory teams. Your insights will be crucial in identifying new opportunities for best practices across technology platforms to ensure consistency in how we utilize systems. If you’re someone who loves harnessing the latest technologies like Oracle Apex, AWS tools, and low code development for collecting and integrating data, this is the role for you! You’ll work hand-in-hand with diverse teams to optimize existing technologies and solve complex business problems. At Biogen, we believe in an inclusive environment where everyone's contributions matter, and we’re committed to providing growth opportunities that align with our mission to deliver life-changing medicines. If you’re passionate about technology and want to make a difference, we’d love for you to join our team where you can truly make an impact!

Frequently Asked Questions (FAQs) for Associate Director, Safety Analytics Role at Biogen
What are the primary responsibilities of the Associate Director, Safety Analytics at Biogen?

As the Associate Director, Safety Analytics at Biogen, your primary responsibilities will include overseeing the transition of our reporting environment to Snowflake architecture, providing technical leadership on software implementations for Pharmacovigilance and Regulatory teams, and developing a technology strategy that aligns with Biogen's overall initiatives. You’ll be actively involved in identifying process improvements and ensuring best practices are implemented across technology platforms.

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What qualifications are needed for the Associate Director, Safety Analytics position at Biogen?

To qualify for the Associate Director, Safety Analytics role at Biogen, candidates should possess advanced experience with drug safety reporting databases like ArisG, Argus, or Veeva. Practical experience with low-code development tools and expertise in database programming, particularly in Snowflake and Oracle, are also essential. Additionally, a strong understanding of AI and its business implications will be beneficial in this position.

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How does Biogen support the professional development of the Associate Director, Safety Analytics role?

At Biogen, professional development is highly valued, especially for roles like Associate Director, Safety Analytics. The company offers tuition reimbursement of up to $10,000 annually, encourages participation in Employee Resource Groups, and provides ample opportunities for skill expansion through hands-on projects involving innovative technologies. These efforts are aimed at fostering growth within a dynamic and collaborative work environment.

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What is the work culture like for the Associate Director, Safety Analytics at Biogen?

Biogen embraces a work culture that prioritizes inclusion and belonging. As an Associate Director, Safety Analytics, you will be part of a diverse team that values individual contributions. The company encourages collaboration and innovation, empowering employees to take initiative in their roles while working towards the shared mission of delivering life-changing medicines. An emphasis on professional growth and a supportive environment makes Biogen a great place to work.

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What technologies will the Associate Director, Safety Analytics work with at Biogen?

In the role of Associate Director, Safety Analytics at Biogen, you will engage with a variety of technologies, including database systems such as Snowflake and Oracle, low-code development tools like Oracle Apex and Appian, and emerging technologies related to Artificial Intelligence. Your proficiency with these systems will be crucial in optimizing processes related to Safety and Regulatory Operations.

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Common Interview Questions for Associate Director, Safety Analytics
Can you describe your experience with drug safety reporting databases?

When addressing this question, highlight specific databases you have worked with, such as ArisG, Argus, or Veeva. Discuss your role in these projects, focusing on outcomes you achieved through database management, reporting processes, or system optimization.

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What strategies do you use to collaborate with IT for software implementations?

In your response, emphasize your communication skills and collaborative approach. Provide examples of how you have worked in cross-functional teams, shared feedback effectively, and aligned project goals with IT capabilities to ensure successful software implementations.

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How do you approach identifying technology improvements in a regulatory environment?

Discuss your analytical skills and process-oriented mindset. Explain how you assess current systems, collect stakeholder feedback, and research new technologies, emphasizing your experience in implementing improvements that comply with regulatory standards.

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What is your experience with low-code development tools?

Talk about specific projects where you've utilized low-code platforms like Oracle Apex or Appian. Highlight how these tools enabled you to streamline processes, enhance user experiences, or solve particular business problems effectively.

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How do you ensure best practices are followed in system utilization?

Illustrate your commitment to quality by explaining how you establish standardized guidelines and provide training or resources to team members. Stress the importance of continuous learning and staying informed about industry standards to maintain compliance.

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Can you give an example of a complex business problem you solved using technology?

Prepare a concrete example from your past experiences where you used technology to address a challenging issue. Describe the problem, the technology you implemented, and the successful outcome, underscoring your problem-solving capabilities.

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What are the key considerations when migrating data to a new system?

Discuss your approach to data migration, including data integrity checks, planning for potential disruptions, involving stakeholders, and ensuring compliance with regulatory requirements. Your methodical approach will reflect your strong attention to detail.

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How do you stay current with advancements in AI and their implications for drug safety?

Explain your commitment to continuous professional development, noting any industry literature, webinars, or training sessions you engage with. Show how you apply this knowledge to anticipate and leverage AI advancements within your role.

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What role does communication play in the success of your projects?

Emphasize the importance of clear and effective communication among team members and stakeholders. Provide examples of how you've fostered open communication channels to ensure everyone is aligned and projects stay on track.

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How would you prioritize competing projects or initiatives?

Articulate your prioritization strategy, including how you assess the urgency and impact of each project. Discuss how you involve key stakeholders in the decision-making process to align priorities with business goals.

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DATE POSTED
April 2, 2025

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