Director, Biostatistics

at Sumitomo Pharma in Springfield, Illinois, United States

Job Description

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Biostatistics The Director of Biostatistics will provide strategic and statistical direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. The Director will be responsible for implementing consistent statistical conduct for the responsible projects and liaising with global Data Science team and clinical research personnel in order to identify and meet their statistical support needs. Additionally, this position will play a role in supporting Real-World Data (RWD) and Real World Evidence (RWE) efforts, enabling the RWD team to generate supportive evidence for regulatory purposes, enhancing the value of our commercialized assets, and improving the success of our clinical programs. The Director will also represent Biostatistics in meetings with executive committees, commercial, regulatory agencies, and external development partners. This position reports to Head of Computational Research and Analytics.

Job Duties and Responsibilities

+ Statistical Expertise: Serves as a Subject Matter Expert, providing statistical expertise to study designs and clinical development strategy to ensure scientific integrity.

+ RWD/RWE Integration: Collaborates with RWD team to generate RWE for regulatory submissions, support label updates, and enhance commercial and clinical program success. In addition, provides inputs to the RWD/RWE strategy.

+ Analysis Plans: Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.

+ Methodological Application: Utilizes methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques.

+ Regulatory Support: Provides input to development programs, including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements.

+ Health Authority Engagement: Prepare statistical analysis plans, and contribute to statistical methodology discussions with Health Authorities.

+ Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques.

+ Protocol Preparation: Presents and discusses statistical considerations as the representative of the Biostatistics function at Protocol Review Meetings.

+ Regulatory Document Preparation: Writes and reviews regulatory documents including statistical analysis plans for integrated summary of safety (ISS),integrated summary of efficacy (ISE),statistical summary reports, and regulatory briefing books.

+ Inter-department Collaboration: Collaborates closely with Clinical Data Management, Statistical Programming, Clinical Research, Global Drug Safety, Regulatory and Project Management. Ensures that study/project-related biostatistics and programming work is carried out in a timely and compliant manner.

+ Leadership and Innovation: Collaborates with cross-functional clinical development teams, researches and applies new statistical procedures and keeps abreast of advancements in relevant fields.

+ Communication and Presentation: Present and discuss statistical considerations, analysis methodology, findings in various internal and external forums.

Key Core Competencies

+ PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

+ Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials. CNS, urology, women’s health or oncology therapeutic area expertise is a plus.

+ Requires proficiency in SAS and R and an understanding of clinical data processing.

+ Knowledge of CDISC requirements for SDTM and ADaM.

+ Knowledge of FDA and ICH regulations/requirements as they pertain to the analysis, presentation/reporting, and monitoring of data.

+ Knowledge and experience of generating RWE for regulatory purpose is plus.

+ Understands roles of Biostatistics, Statistical Programming and Data Management and provides adequate statistical expertise within a cross-functional team in clinical development.

+ Knowledge of other statistical and computational software packages (R, EaST, nQuery) is required.

+ Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions.

Communication & Interpersonal Skills

+ Excellent verbal and written communication skills.

+ Ability to effectively collaborate in a dynamic environment.

Significant Contacts :

+ Interacts internally with global Data Science team (Biostatistics, Programming, Data Management), Real World Data Science within Computational Research and Analytics, Clinical Development/Operations and Regulatory concerning projects, operational decisions, or commitments impacting Biometrics and/or other functional areas.

+ External interactions involve CROs and SMPA’s corporate partners.

Education and Experience

Education

+ Ph.D. and 8+ years of experience in Biostatistics; M.S. and 10+ years of experience in Biostatistics with extensive experience within the Pharmaceutical and/or Biotechnology industries

Experience

+ Experience with analysis and reporting of phase 3 study data, as well as integrated summary of efficacy and safety (ISE and ISS).

+ Experience with group-sequential designs and/or support of independent data monitoring committee for registration trials.

+ Experience with statistical methodology and analysis for clinical trials and RWD studies in CNS, Urology, Ophthalmology, endocrinology or oncology.

+ Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions desired.

+ Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.

+ Works independently, self-directed, high energy and strong work ethic. High degree of creativity, problem solving, latitude and attention to detail required

+ Ability to work in a small, fast-paced environment covering a range of activities from document creation to agency interactions as the need arises

+ Demonstrated strong leadership, project management, teamwork, and interpersonal skills

+ Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used.

The base salary range for this role is $189,400 to $236,700. Base salary is p