Statistician - Drug Safety Analyst - REMOTE
You will support pharmacovigilance tasks and prepare regulatory and internal documents with precision and compliance. These tasks help ensure that potential safety issues are identified and addressed promptly, contributing to the overall safety and efficacy of pharmaceutical products. Your work will support product safety signal detection and product safety risk management.
Key Responsibilities:
- Adverse Reaction Trending: Identify patterns and trends in adverse drug reactions (ADRs) over time to detect emerging safety signals.
- Signal Detection: Use statistical methods to detect signals of potential safety issues from spontaneous reporting databases.
- Graphical Representation: Create visual summaries such as line graphs or heat maps to illustrate trends in ADRs.
- Safety Reports: Prepare detailed safety reports analyzing ADR trends and frequencies for submission to regulatory authorities.
- Risk-Benefit Analysis: Support risk-benefit analyses to assess the overall safety profile of a drug in light of observed adverse events.
Required Qualifications:
- Degree in Statistics or Biostatistics: A bachelor's or master's degree in statistics, biostatistics, or a related field is essential.
- Analytical Skills: Knowledge of various signal detection methods such as disproportionality analysis and Bayesian approaches. Ability to perform trend analysis and identify patterns in ADR data.
- Data Management: Skills in managing large datasets and using databases specific to pharmacovigilance.
- Report Writing: Strong skills in writing clear and concise safety reports.
- Collaboration: Ability to work effectively with cross-functional teams, including clinical research, regulatory affairs, and medical affairs.
- Pharmacovigilance Training: Specialized training or certification in pharmacovigilance can be highly beneficial.
- Regulatory Knowledge: Understanding of regulatory requirements and guidelines for drug safety reporting (e.g., FDA, EMA guidelines).
- High level of accuracy, attention to detail, and quality in all tasks.
We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Pay range is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Talascend also offers a variety of benefits including: health and disability insurance, 401(k), EAP, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, plan requirements, schedule type, and client work site mandates.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.