Associate Director, Biostatistics

Rockville, MD

Full time

R11168

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical leadership role for driving development of protocols and statistical designs in early phase clinical trials to support critical development decisions and advance drug candidates through clinical development.

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This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Director, Biostatistics.

Job Description:

• Provide strategic statistical leadership for early development programs, including First-in-Human (FIH), Phase 1, Phase 1b/2a, and proof-of-concept studies.

• Lead statistical input into study design, protocol development, analysis planning, interpretation, and reporting of early-phase clinical trials.

• Develop innovative statistical strategies to address key development questions related to safety, dose selection, proof-of-concept, and go/no-go decisions.

• Serve as the lead statistician for one or more assets and represent Biostatistics on cross-functional asset teams.

• Partner closely with Clinical Development, Clinical Pharmacology, Clinical Management, Regulatory Affairs, Data Management, and Statistical Programming.

• Drive evidence-based decision-making through integration of safety, efficacy, PK/PD, biomarker, and translational data.

• Support key development milestones, including proof-of-concept evaluations, dose selection, and development planning.

• Influence program strategy by assessing development risks and recommending statistically sound approaches to maximize probability of success.

• Serve as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline.

• Manage, mentor, and develop biostatisticians, fostering technical excellence.

Qualifications/ Required:

Knowledge/ Experience and Skills:

• Understand the company's products, the competition, and the pharmaceutical industry in general.

• Demonstrate a competent knowledge of the company's work tools, processes, and policies.

• Maintain a current awareness of new drug developments and statistical methodologies in the business.

• Demonstrated experience leading Phase 1 and early-phase clinical studies, including FIH, dose-escalation, dose-expansion, and proof-of-concept trials.

• Strong working knowledge of applicable U.S. regulatory requirements relevant to clinical trial design, analysis, and reporting.

• Proven ability to partner effectively with Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory Affairs, and other key stakeholders.

• Experience working within matrixed, multidisciplinary drug development teams.

• Ability to influence decisions in a matrix environment without direct authority.

• Demonstrated ability to support and champion novel statistical approaches that improve decision-making when working with limited or variable early phase clinical data.

• Ability to communicate complex statistical concepts and insights clearly to technical and non-technical audiences.

Skills:

• In-depth knowledge of statistical principles, applications, and SAS/R programming software.

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

• Knows how/when to apply organizational policy or procedures to a variety of situations.

• Ability to manage multiple programs and competing priorities.

Educational Qualifications:

• PhD or Master's degree in Statistics or Biostatistics

• Minimum 7 years (PhD) or 9 years (Master's degree) of experience in the pharmaceutical industry Experience in CNS area is a plus

• Experience with early phase clinical trials, preferably first-in-human or PK/PD/biomarker-focused studies is a plus

Our Benefits:

• Comprehensive medical, dental, vision and prescription drug coverage

• Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance

• Tuition reimbursement

• 401(k) match

• FTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline : This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (View email address on click.appcast.io) .

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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.