Senior Epidemiologist

Job ID: 8895671
Job Title: Senior Epidemiologist
Job Location: Cambridge, MA
Duration: 12+ Months

Job Description: Senior Epidemiologist
Duties:
· Primary liaison between the assigned Therapeutic Area and key stakeholders to ensure translation of the Clinical Development Plan into observational research deliverables. Actively participates to provide epidemiological expertise and determine appropriate strategies to acquire data, design and execute epidemiological research to provide critical insight into execution of clinical development and assessment of post-marketing data. Responsible for the development and implementation of the observational research strategy and epidemiological content of the Clinical Development Plans. Participates and presents in Sr. Management boards for assigned key Therapeutic Areas
· Responsible for the design, planning, coordination and execution of all aspects of (major/complex) epidemiology research programs / studies, acting as first point of contact, liaising with Clinical Operations and guiding the study execution team internal and of the external parties (e.g. CRO, academia). This includes authorship of the study protocol and related documents (e.g., study protocols, statistical analysis plans, data collection forms, procedure manuals, study progress reports, study results reports, etc.) to ensure that the scientific content/ rigor is consistent and with the highest quality across the observational research program. Manage contractual and budget requirements. Participates and presents in in Sr. Management boards.
· Responsible for the progress of observational studies by monitoring timelines, deliverables and budget. Identifies deficiencies and issues that adversely affect the conduct of research projects and formulates and implements plans for their mitigation. Independently troubleshoot, identify technical problems in the execution and independently pursue solutions to ensure objectives are met efficiently and in a timely manner.
· Contributes to the writing of relevant components of regulatory dossiers and product related documents (PSURs, RMPs etc.) through authoring and review of key sections for observational studies/epidemiological data. Contribute to the observational/epidemiological aspects of regulatory and clinical development plan strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle. Work with the Head of Epidemiology on the preparation of observational/epidemiological sections for regulatory filings and meetings as needed.
· Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of epidemiological programs and studies to internal and external stakeholders and colleagues with varying levels of epidemiologic research knowledge. Prepare manuscripts for submission to peer-reviewed journals. Participate in discussions with internal and external stakeholders, including technical personnel at regulatory agencies and clinical investigators. Acquisition of other scientific / epidemiological information.
· Liaises with internal stakeholders, including Project Management, Clinical Development Operations, Data Management, Statistics, Commercial, Medical and Regulatory Affairs, in a matrix environment for planning or to maximizing the value proposition of late-phase or marketed Seqirus products according to strategic objectives for assigned therapeutic areas. data in alignment with specific project needs / plans.
· Develop Best Practices, SOPs, templates, work instructions, etc. for Epidemiology. The role makes significant independent contributions to business improvement projects for Epidemiology to improve overall department output at reduced costs.

Skills:
· Ability to plan strategically for the optimal application of epidemiological research in product development and post-marketing support
· Ability to work cooperatively and successfully in a matrix organization and across multiple disciplines
· Strong interpersonal and decision making skills
· Strong organizational skills and ability to prioritize individual and workloads of direct reports
· Proficient in critically evaluating, interpreting and summarizing complex epidemiologic (study) data
· Strong verbal, written and presentation skills and fluent written and spoken English.
· Thinks globally and contemplates multiple aspects and impacts of issues, plans proactively and use clear judgment
· Professional and supportive to changes in the business.
· Exhibits company norms and values.

Qualifications:
· Minimum Degree: (J.D., M.D., D.D.S. or Pharm. D.)
· Advanced degree (MD, PhD or PharmD) relevant life science/ healthcare (preferred) or Bachelor/Master degree or equivalent education/ degree relevant life science/ healthcare with specific training in Epidemiological methods.
· Minimum of 3 years' experience in (clinical) epidemiological research or public health, preferable in industry environment. For Bachelor/Master degree if accompanied by 4-7 years related work experience.
· Involvement in cross-functional, multicultural and /or international teams essential.
· Experience with multiple epidemiological methods, including retrospective secondary analyses of administrative databases preferred.
· Knowledge of the drug or vaccine development process. Knowledge on the applicable regulation of observational studies.