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.

Essential Functions Required for Job
• Lead Statistical Efforts: 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.
• Develop and Oversee Statistical Documentation: 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.
• Mentor and Manage Team Members: Provide coaching and management for junior biostatisticians, fostering their professional development and ensuring high-quality output.
• Oversee CRO Statistical Activities: Plan, manage, and supervise the statistical activities conducted by Contract Research Organizations (CROs) to ensure alignment with project objectives and standards.
• Provide Technical Guidance: 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.

Knowledge, Skills and Abilities (general & technical):
• Leadership and Management: Demonstrated capability to lead and mentor teams, manage multiple projects simultaneously, and drive results in a fast-paced environment.
• Communication Skills: Strong written and verbal communication skills with the ability to present complex statistical concepts to both technical and non-technical audiences.
• Collaboration: Proven ability to work effectively as part of a cross-functional team, fostering a positive and productive work environment.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to make strategic decisions based on data-driven insights.
• Project Management: Ability to plan, organize, and manage biostatistical aspects of projects from start to finish.
• Statistical Expertise: In-depth knowledge of statistical methods and their application in oncology clinical trials, including experience with Bayesian modeling, complex trial designs and analysis techniques.
• Software Proficiency: Proficient in statistical programming languages and software, such as SAS and R, with the ability to guide data analysis and interpretation.
• Regulatory Knowledge: Familiarity with regulatory guidelines and standards (e.g., FDA, EMA, ICH) relevant to biostatistics and clinical trials.
• Data Standards: Experience with data standards such as CDISC SDTM and ADaM, including overseeing the development and quality control of specifications.
• Quality Control: Strong attention to detail and commitment to ensuring the accuracy and integrity of statistical analyses and programming outputs.

Education & Experience Requirements:

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

The base salary range for this role is

$165,800.00 - $207,200.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

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Associate Director, Biostatistics