Associate Manager, Biostatistics - Northbrook, United States - Astellas

Astellas

Verified Company

Northbrook, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Purpose and Scope:

Member of the extended statistical team, the primary purpose of the Manager is to contribute to the design, analysis, and reporting of clinical trials/observational studies under the supervision of a more senior Statistician.

The position can also act as a Methodology Statistician independently validating the execution of routine common statistical technique and identifying situations where novel techniques may be appropriate.

The position is expected to complete routine tasks with an appropriate level of independence and in accordance with the project direction and standards.

For more complex tasks, the position works under the supervision of a more senior Statistician.

Essential Job Responsibilities:

Astellas is looking for diverse talents, self-motivated and eager to make a difference for the patients, therefore responsibilities listed below are characteristic of the type and level of work; not all are expected to be carried out.

Contributes to the efficient planning, execution and reporting of clinical or observational studies, post hoc, HTA, regional, PK-PD or Biomarkers analyses with an appropriate level of independence

Is responsible for the quality and timeliness of all statistical deliverables of the assigned tasks

Authors / reviews:
synopsis, protocol, statistical analysis plans (SAP), Case Report Forms (CRF), Data Validation Plans, tables listings and figure (TLF) specifications

Performs statistical analyses in accordance with protocol, SAP, good statistical practice, and available regulatory guidelines.

Reviews all outputs for validity and completeness. QC inferential statistical analyses.

Monitors timelines and progress, leads and organizes review meetings, such as TLF review meetings, and classification meetings.

Contributes to clinical study reports, other reports or publications by providing statistical interpretation of the results.

Personal Development / Collaboration
Collaborates with other study team members (e.g. programmer, data manager, clinical study manager, study medical lead) influencing team members from all disciplines on statistical design, analysis and methodology topics

Partners and communicates effectively with other Data Science (DS) functions; in particular provides Statistical Programmers with study details, timelines, specifications, and efficacy analyses algorithms.

Statistician and Programmer communicate frequently and update each other on progress of individual deliverables.

Develops expertise beyond statistics by researching medical literature, understands clinical, regulatory, and commercial landscape and builds an adequate network with academic, regulators and industry peers

Keeps current on statistical methodology and programming skills

Organizational Context:

Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.

This position reports to a Director, Sr Director or Executive Director.

This position is an individual contributor role.

This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations or Exploratory statistics in SRS and a member of a deliverable team.

Qualifications:

Required
Good knowledge and skills in SAS required, knowledge of R preferred

Understanding of pharmaceutical industry leading practices (e.g., regulatory framework, inspection process, HTA guidance, technologies, systems)

Understanding of and experience with pharmaceutical datasets, statistical methodology, P,V and NIPASS from data identification landscaping, etc.; Understanding of how to transform research objectives into study design, regulatory publications, and abstracts

Working knowledge of pharmaceutical vendors/CROs and how they are used to execute on Data Science activities

Understanding of the DS lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization process, etc.)

Understanding of statistical principles, methodology and algorithms (including analyzing and interpreting data in a research environment)

Understanding of how data is being used and applied (e.g., models), what DS is doing across different activities for a product, and how DS is building something bulletproof from an evidence perspective

Hands-on programming experience within one or more statistical/data science programming languages (e.g., R, SAS, or Python) - including data manipulation and analysis of a wide array of data sources/types

Understanding of and experience with how to read, interpret, and communicate scientific concepts/data; Understanding of observational methods

Shows ability to read, analyze, and communicate large and small amounts of data effectively including teaching/explaining data-driven results to others; Applies experienc