Director, Biostatistician - Remegen Biosciences, Inc.

ORGANIZATION

RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Biosciences is a wholly owned subsidiary of RemeGen Co., Ltd. a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.

POSITION SUMMARY

As the Director of Biostatistics, you will play a crucial role in guiding RemeGen Bioscience’s global clinical development programs in the area of autoimmune diseases. You will serve as the company’s global area expert in statistical, data science, programming, and data management, providing strategic leadership in these domains. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.

KEY RESPONSIBILITIES
 

• Strategic Leadership: Provide strategic guidance as the expert in statistics, data science, programming, and data management for global clinical development.
• Clinical Development and Regulatory Interaction: Offer biostatistical input for overall clinical development strategies, protocol design, statistical analysis plans, and regulatory interactions. Handle briefing books, submissions, and address requests and positions from regulatory agencies.
• Global Clinical Studies Management: Plan, monitor, and analyze global clinical studies. Coordinate the development and review of statistical aspects of regulatory submissions.
• Vendor Management: Manage and oversee biostatistical, programming, and data management aspects of vendors, including CROs, IRT, eCOA, etc.
• Cross-Functional Collaboration: Work closely with global medical, clinical operations, regulatory, and safety teams to ensure efficient execution of global clinical trials.
• Statistical Analysis Execution: Oversee global statistical analyses, including tables, listings, and figures. Prepare statistical methods and results for study reports and contribute to data interpretation and decision-making processes.
• Data Collection and Design Support: Provide guidance on data collection, design, and analysis for global studies. Ensure efficient medical and safety data review and monitoring.
• IDMC Activities Management: Manage blinded and unblinded Independent Data Monitoring Committee (IDMC) activities, from strategy development to generation of Trial Listing Files (TLFs).
• Methodological and Regulatory Standards Maintenance: Keep up-to-date with statistical methods, industry standards, and regulatory requirements.
• Clinical Study Documentation Preparation: Prepare clinical study documents for eCTD clinical modules. Familiarity with CDISC standards, IWRS, ADaM Specs, and review define documents.
• Molecule Development and Commercialization Support: Contribute statistical expertise to support molecule development and commercialization strategies, including post hoc analyses and interpretation of results.
   

REQUIREMENTS
 

Education:	Master’s degree in Biostatistics, Statistics, or related filed required. Ph.D. in related field, preferred.
Experience:	At least 10 years’ experience, responsible for biostatistics of clinical trials. Experience collaborating with scientific teams to design robust experiments and clinical trials. Demonstrated experience applying statistical theories and methods to solve complex biological problems. Experience using statistical software such as R, SAS, or SPSS for data analysis and modeling. Familiarity with complex statistical methods that apply to applicable clinical trials.
Skills:	Strong analytical thinking and problem-solving abilities. Ability to handle multiple projects simultaneously. Excellent written and verbal communication skills. Ability to work cross-functionally in a fast-paced, collaborative environment. Strong attention to detail.

OTHER
 

Supervisory Responsibilities:	None.
Equipment To Be Used:	Laptop computer, other office equipment, and/or lab equipment.
Typical Physical Demands:	Manual dexterity sufficient to operate standard office equipment.
Working Conditions:	Works remotely or in the office. Occasionally called upon to work hours in excess of your normal daily schedule. Requires up to 10% travel as needed.

COMPENSATION & BENEFITS
 

Benefits:

401(k) and matching program Medical, Vision, and Dental Insurance Flexible Spending Account Short- and long-term disability Life insurance Employee Assistance Program Employee discounts Paid time off/vacation/sick time Professional development assistance Referral program

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from employer.
 

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