Associate Director, Patient Reported Outcomes (Pro) Statistics

Job Description

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

 

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

 

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

 

Purpose and Scope:

The Associate Director acts as an independent statistician, representing Data Science as a statistical expert in the domain of Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs) and Observer/caregiver-Reported Outcomes (ObsROs). They take a lead role of the statistical perspective on developing and executing project-specific strategies for one or more projects as related to the analysis of these instruments (collectively, xROs). This person will combine knowledge of clinical development and post-approval studies to consult on appropriate analyses of xROs as study endpoints, and either oversee or directly execute analytic tactics as appropriate.

 

Essential Job Responsibilities:

• This is a dual role with advising in the planning, development, and use of xROs as well as contributing broadly as a member of a team focusing on the analysis of studies containing these instruments. The role is responsible for providing statistical input to project development plans and study analyses plans including PROs, and may include answering questions from regulatory authorities around PRO analysis.
• The successful candidate is expected to complete these tasks with minimal supervision, by appropriately and pro-actively seeking line management alignment and intervention when needed to ensure successful outcome (e.g., with respect to project resource requirements or key strategic functional issues.)
• Participates in project teams as needed for planning and development of analysis plans regarding xROs
• Provides statistical advice to study and project teams related to xRO data and analysis including design of studies and analyses requiring advanced statistical methodologies. Recognizes and addresses xRO issues which may impact the statistical integrity of the development program or for which statistical tools may add value.
• Provides best-in-class data science support to Astellas drug development programs in relation to xRO, and liaises with affiliates to deliver on post hoc analyses of xRO data for HTA needs in partnership with HEOR.
• Ensures quality and consistency of key data science deliverables across studies. Ensures creation of, maintenance and adherence to PRO specific analysis standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.
• Represents the company on statistical matters related to xRO data analysis at meetings with regulatory authorities, key opinion leaders and similar experts/bodies
• Reviews key project and study documents to ensure optimal statistical presentation and compliance.
• Provide advice and guidance on statistical considerations around operational collection of xRO data.
• Provides statistical advice on application or amendments to developer scoring algorithms, establishment of within-trial MCID, preparation of Type C xRO briefing materials

For studies within assigned projects

• Writes, reviews, or contributes to key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports, publications.
• Ensures efficient planning, execution and reporting of xRO related endpoints of critical documents such as CRFs, Data Validation Plans, data specifications, TLFs
• Ensures statistical analyses are performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.

When statistical support for study deliverables that are contracted to a CRO:

• Contributes to vendor selection with partner functions, e.g., supporting verification of vendor’ statistical capabilities and approaches.
• Performs statistical oversight: Ensures CRO is provided with details, timelines and Astellas specifications and requirements and is kept up to date in case of changes. Monitors timelines, progress, and specific issues for analytics, and acts as necessary. Ensures statistical review of the outputs created by the CRO.

Other tasks and roles may include:

• Contributor to cross-departmental/departmental/sectional improvement initiatives
• Member or leader of external industry or academic and professional organizations.
• Perform vendor qualification / audits in collaboration with functional management
• Investigates new statistical methodology and feeds back to department and project teams

Quantitative Dimensions:

Qualified biostatistical expertise for clinical studies and drug submissions is a regulatory requirement, and they must be carried out in accordance with international regulations (ICH, FDA, PMDA, EMA) and internal Astellas SOPs and standards. The results must be reproducible and statistically sound and are subject to internal and external inspections. Flawed statistical input to drug development projects may result in failure to achieve marketing authorization, market access or regulatory approval delays resulting in substantial financial loss for the company.

 

Organizational Context:

• The Data Science department provides statistical, biometrical and data management / warehousing expertise for all R&D projects and marketed products, encompassing Phase I-IV studies.
• Reports to Senior Director Real World Data Science. Closely collaborates with project team members (e.g., project leader, development operations lead, medical lead, HEOR, regulatory affairs, clinical pharmacology, and project management).
• May be a member of study teams for assigned projects. Manages to achieve successful outcome through direct contribution, delegation of work, and coaching of assigned team members within own functions. Provides guidance to & mentors less experienced statisticians.

Location(s)Northbrook, IL
Requirements

Qualifications:

Required

• M.S. or Ph.D. in statistics or equivalent degree/experience
• Minimum of 5 years of experience in applying statistical methods in biomedical research, PRO data/analysis, extensive pharmaceutical or CRO experience required or demonstrated ability to provide statistical direction in these areas
• Ability to combine knowledge of clinical development and to utilize knowledge from PROs in clinical trials with clinical trial endpoint data into the strategy for progressing development projects.
• Experience in working on clinical project teams and providing statistical expertise in PROs.
• Good understanding of entire drug development process with ability to see the “big picture”.
• Experience as the statistician in regulatory interactions preferred
• Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of PRO data
• Knowledge and skills in SAS required and knowledge of other statistical software preferred.
• Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.
• Ability to work in a matrix environment.
• Proven excellent organizational, project and time management skills.
• Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians
• Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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