Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases, and cardiovascular conditions.
An exciting opportunity has arisen for a Manager, Epidemiology to join our Drug Safety and Public Health team based in Stockley Park, Uxbridge.
Specific Responsibilities and Skills for Position:
The Manager within the department of Epidemiology, Drug Safety and Public Health (DSPH) designs, directs, and executes observational studies, including pharmaco-epidemiological studies and non-interventional studies.
The Manager maintains a thorough knowledge of epidemiologic principles, analysis methods and data resources as well as indications for their appropriate use.
The Manager contributes to and may lead interpretation of analysis results and preparation of study reports, conference abstracts and presentations, and manuscripts.
The successful candidate will also demonstrate a thorough knowledge of statistical programming principles, analysis methods and data resources, as well as indications for their appropriate use.
Essential Duties and Job Functions:
• Support and/or lead other Epidemiology activities, including interaction with CROs, to accomplish business objectives.
• Provide epidemiologic input into Pharmacovigilance Plans, and may contribute to Risk Evaluation and Mitigation Strategy programs.
• Participate in special projects based on extensive knowledge base, experience and competency.
• Ability to build and maintain complex and efficient SAS routines, using SQL, macros, and multi-processing techniques.
• Contribute to and may lead internal and external educational initiatives.
• Contribute to preparation and review of safety documents in response to regulatory authorities.
• Provide epidemiologic expertise.
• Review, synthesize, and critique the literature.
• May identify, assess, and integrate/implement new data resources, methods, technology and analytic tools.
• Oversee and/or actively contribute to the completion of all analytical/validation activities for studies/projects, in collaboration with Epidemiology Programming.
• Actively contribute to identification and assessment of safety signals and trends using active surveillance methods.
• Oversee and/or actively contribute to analysis/validation projects utilizing industry-standard analytic tools.
• Develop and/or review protocols and Statistical Analysis Plans.
• Participate in and may lead intra-departmental and inter-departmental cross-functional project teams.
• Participate in process improvement initiatives, including SOP/WRK updates and audits.
• Demonstrate excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines.
• Successfully interacts with other groups within DSPH.
• Mentor junior departmental staff to ensure competence in epidemiologic skills and knowledge.
• May participate in recruitment and hiring of personnel.
Knowledge, Experience and Skills:
• High proficiency in the field of Epidemiology.
• PhD or a MD/PharmD + MPH/MS in Epidemiology or related field.
• or MPH/MS in epidemiology or related field with some work experience in a research or academic institution.
• Pharmaceutical industry and/or CRO experience is a plus.
• Exceptional analytic, problem-solving, and critical thinking skills are required.
• Excellent written and verbal communication and interpersonal skills are required.
• Ability to work in a rapid, agile project style environment is required.
• Knowledge of Microsoft Office, including Word, Excel, and Powerpoint is required.
To find out more about this position and apply, please visit:
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