The Associate Director will be a key and integral member of the HEOR analytics capability providing insights and analytics on real world patient, provider, and payer experiences across the rare disease therapeutic areas. In this role you will support all aspects of health economic modeling, Health technology assessments, payer evidence generation, outcomes research for medical, regulatory, and commercial strategy. You will conduct robust statistical analysis of real-world data, patient registry data sets and secondary analysis of clinical trial data sets in your day-to-day role. Critical to the success of this role will be in providing impactful insights for shaping the strategy around Alexion’s therapies. Success will be measured by impact of your work on the access of our medicines to and thereby saving lives of our patients.
You will be responsible for:
- Managing and executing analytics projects using clinical trial and real-world healthcare data sets. These projects will support internal stakeholders within HEOR and broader GMA and commercial functions on all aspects related to patient treatment experience, disease burden and progression, health authority submissions, insights to support payer discussions, reimbursement, and pricing/commercial strategies.
- Building and maintaining a strong relationship with all internal stakeholders within HEOR, across Development/Biostatistics and GMA functions and external collaborators supporting the HEOR analytics capability.
- The reverse feedback from HEOR team, to influence the clinical development strategy will be a significant goal of this role. The associate director will engage regularly with study development team, medical directors to consult on clinical study design and objectives addressing the health economic modelling, payer and health authority submissions needs.
Key responsibilities include:
- Providing timely insights to HEOR US and global teams on patient, physician, and payer data on the rare disease indications of interest to Alexion using robust statistical and data analytics approaches. These methods include but not limited to the use of classical statistical approaches for parametric multivariate regressions and non-parametric tests on categorical data, time to event and survival analysis, Bayesian inferences, sequential testing, multiple comparisons, and sub-group analysis etc.
- Adoption of innovative advance analytics and statistical learning approaches will be expected of this role from time to time, demonstrating a passion for creative analytics approaches to answer complex questions with limited data.
- Demonstrate expertise in statistical and real-world data methods by contributing to external awareness through presentations and publications at conferences and journals and champion the value and use of robust and advanced analytics for the success of HEOR and value to our patients.
- Develop a good understanding of the disease etiology, symptoms, disease management practices, patient, caregiver, and payer experience with respect to these rare indications.
- Understanding of development strategy of Alexion’s pipeline including all planned, ongoing, and past studies, bringing insights from internal and external clinical trials for health economics and patient outcomes strategy.
- Roughly about 60% of day-to-day responsibilities will be to bring expertise in statistical methodology, working closely with our biostatistics and epidemiology colleagues, engaging in data access and sharing and conducting meta-analysis as well as analysis of secondary endpoints from clinical trial data to support HEOR and payer strategy.
- Hands on programming and analysis of data sets as well as managing external consultants to conduct robust and quality analysis of data will be a core activity for this role.
- Good organizational and project management skills, from planning of projects, selection of vendors and governance of external collaborations will be a key part of the job.
You will need to have:
- 7+ years’ experience in the pharmaceutical or CRO industry in a hands on role covering data analytics with at least 2-3 years in a biostatistics or statistical programming function and a good understanding of drug development value chain.
- Must show evidence of strong project management skills, planning and execution of projects including external collaboration.
- Experience creating, managing and analyzing clinical study data in CDISC SDTM and ADaM models and transforming raw data into those standards
- Experience and understanding of drug development systems and processes, various instruments of clinical studies, from study protocols, eCRFs, ePRO to statistical analysis plans and CSRs.
- Strong verbal and written communication skills – ability to clearly and effectively present information.
- Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
- Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
- Advanced experience with:
- Constructing technical programming specifications.
- Relational Databases.
- Good Clinical Practices.
- Good Programming Practices.
- 21CFR Part 11 Standards.
- Creating all files necessary to support an electronic submission in the eCTD format.
- BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease.
This job is posted by Alexion.
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