Associate Director, Biostatistics

Sumitomo Pharma•Marlborough, MA

20h•Hybrid

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. This position reports to the Executive Director of Biostatistics and is an integral part of the oncology biostatistics team. The team supports all statistical deliverables within SMPA's oncology clinical development. The role involves leading statistical activities for oncology clinical projects and ensuring effective collaboration and alignment with cross-functional teams.

Requirements

Demonstrated capability to lead and mentor teams, manage multiple projects simultaneously, and drive results in a fast-paced environment.
Strong written and verbal communication skills with the ability to present complex statistical concepts to both technical and non-technical audiences.
Proven ability to work effectively as part of a cross-functional team, fostering a positive and productive work environment.
Strong analytical and problem-solving skills with the ability to make strategic decisions based on data-driven insights.
Ability to plan, organize, and manage biostatistical aspects of projects from start to finish.
In-depth knowledge of statistical methods and their application in oncology clinical trials, including experience with Bayesian modeling, complex trial designs and analysis techniques.
Proficient in statistical programming languages and software, such as SAS and R, with the ability to guide data analysis and interpretation.
Familiarity with regulatory guidelines and standards (e.g., FDA, EMA, ICH) relevant to biostatistics and clinical trials.
Experience with data standards such as CDISC SDTM and ADaM, including overseeing the development and quality control of specifications.
Strong attention to detail and commitment to ensuring the accuracy and integrity of statistical analyses and programming outputs.
PhD or MS in statistics or biostatistics. PhD is preferred.
Minimum 5-year (for PhD) or 8-year (for MS) experience in clinical trials is required
Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trial
Strong statistical leadership in a multi-functional project environment: able to manage many projects simultaneously as well as conflicting priorities
Effective writing and communication skills: able to author various statistical documents; able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report
Experience with Bayesian modeling and Analysis
Experienced with SAS programming, R programming and other statistical software

Nice To Haves

Experience with AI or agentic AI in statistical reporting is a plus
People management is a plus

Responsibilities

Serve as the biostatistics lead for one or more studies within a project team, offering expertise in study design, operations, decision rules, and analysis planning.
Author and oversee the production of statistical sections of protocols and analysis plans, and contribute to the statistical sections of publications across multiple clinical projects.
Provide coaching and management for junior biostatisticians, fostering their professional development and ensuring high-quality output.
Plan, manage, and supervise the statistical activities conducted by Contract Research Organizations (CROs) to ensure alignment with project objectives and standards.
Offer guidance to junior statisticians and statistical programmers on developing SDTM/ADaM datasets and TLFs (Tables, Listings, and Figures) specifications, as well as perform quality checks on statistical programming efforts as needed.