Reporting to a Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions. This person will work cross-functionally with internal departments and external resources on Biostatistics-related issues, ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate, and apply technical expertise to the development of biostatistics standards and procedures.
Responsibilities
- Serve as study biostatistician on development programs and multiple studies.
- Author statistical analysis plan, TFL shells and other study-related statistical documents.
- Review AdaM Specification, oversee the generation of AdaMs and TFLs and ensure timely high-quality deliverables.
- Plan and implement statistical analyses, provide statistical input to the clinical study report and perform statistical functions for submission-related activities on the assigned programs.
- Plan and execute exploratory analyses and statistical consultation within applicable cross-functional teams.
- Provide statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned.
- Contribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches.
- Attend and make statistical contributions at cross-functional study team and project team meetings.
- Participate in process improvement, SOP development, training, and enhancing statistical technical expertise.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective manner.
- Adhere to departmental and regulatory agency procedures and standards.
Required Qualifications
- Ph.D. or M.S. in Biostatistics or Statistics.
- Demonstrated good understanding of Phase I to Phase IV drug development.
- Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance.
- Knowledge of statistical analysis software SAS and R.
- NDA/BLA experience with eCTD submission is a plus.
- Dermatology or oncology drug development experience is a plus.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
- Use teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
- Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
- Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.
- Broad experience in an emerging, publicly traded company environment is a plus
The presently-anticipated base compensation pay range for this position is $186,500 to $207,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
