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Biostatistics Program Leader
3 months ago
About Allucent: At Allucent, we are committed to assisting small to medium-sized biopharmaceutical firms in effectively navigating the intricate landscape of clinical trials, aiming to deliver transformative therapies to patients worldwide.
Position Overview: We are seeking a Senior Biostatistics Director to become a vital member of our dynamic team (hybrid/remote). In this role, you will play a crucial part in coordinating the activities of the Statistical department at Allucent. Your responsibilities will encompass overseeing statistical operations, managing direct reports, ensuring optimal resource allocation, supporting business development initiatives, and providing comprehensive statistical project oversight.
Key Responsibilities:
Biostatistical Expertise:
- Possess a strong background in clinical research, particularly in the analysis of clinical trial data.
- Develop and prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for studies of varying complexity.
- Demonstrate familiarity with advanced statistical methodologies and concepts.
- Conduct senior reviews of statistical documents and outputs to ensure quality and integrity across all studies.
- Execute statistical analyses as outlined in protocols or analysis plans, interpreting and communicating results effectively.
- Review and develop statistical sections of study protocols and clinical study reports.
- Prepare randomization materials in accordance with Allucent SOPs and sponsor specifications.
- Support regulatory submissions by addressing statistical inquiries and participating in regulatory meetings as needed.
- Utilize SAS for the production and validation of datasets and statistical outputs.
- Lead complex projects, ensuring effective communication with clients and the statistical team, while monitoring programming efforts.
- Manage project budgets and oversee the identification of out-of-scope work.
- Act as the lead unblinded statistician for studies, managing interim analyses and participating in safety review meetings.
Management and Development:
- Support the learning and development of staff within the organization.
- Identify and implement departmental initiatives to enhance efficiency and quality.
- Provide mentorship to junior staff and manage direct reports effectively.
- Ensure adherence to SOPs and departmental standards among direct reports.
- Monitor performance indicators to assess the effectiveness of the biostatistics department.
- Recruit and expand the biostatistics/statistical programming team as necessary.
Qualifications:
- Graduate degree (Master's or higher) in a relevant field such as statistics, mathematics, life sciences, epidemiology, or healthcare.
- A minimum of 12 years of relevant experience in the field.
- Strong knowledge of GxP and familiarity with applicable regulations and guidelines.
- Proficient in computer systems and applications, with strong analytical and critical thinking skills.
- Excellent written and verbal communication skills, with a strong command of the English language.
- Ability to thrive in a fast-paced environment, demonstrating strong individual initiative and attention to detail.
- Proficient in various computer applications including Word, Excel, and PowerPoint.
- Collaborative and client-focused with strong leadership capabilities.
Benefits:
- Comprehensive benefits package tailored to location.
- Competitive salary structure.
- Departmental budget for professional development.
- Flexible working hours and remote/hybrid working opportunities.
- Leadership and mentoring opportunities.
- Access to internal training programs and growth opportunities.
Note: This position is part of a hybrid work policy that encourages a dynamic work environment.
