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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 decisionmaking 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 firstinhuman or PK/PD/biomarkerfocused 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.

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;https://www.otsuka-us.com/careers-join-otsuka.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.