Remote Pharmacovigilance Associate Jobs (NOW HIRING)

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.

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