Associate Director to Director, Biostatistics

Position: Associate Director to Director, Biostatistics Department: Global Medical-Biometrics and Quantitative Sciences Location: Remote (PST Zone) with up to 20% global and domestic travel Reports To: Executive Director, Biometrics

Position Summary

This position will report to the Executive Director of Biometrics and will provide statistical leadership across programs and trials from early- to late-phase development. The role will contribute strategically to project decisions and study operations, apply innovative statistical approaches (e.g., modeling and simulation, adaptive design, Bayesian methods), support and defend analyses and interpretations in internal cross-functional meetings, and prepare and communicate responses to regulatory agency inquiries.

Responsibilities

• Serve as lead statistician on project teams, providing strategic and operational expertise for all stages of clinical development programs and support of other functions
• Write or review protocols, SAP, CSR and other related documents to ensure scientific integrity of the applied statistical methodology
• Adhere to company standards, and all applicable regulations and guidelines
• Perform or oversee statistical analyses and interpretation of study results. Direct vendors to perform all statistical related tasks
• Collaborate cross-functionally on study design, data standards, and reporting
• Supply statistical input for regulatory submissions and in response to agency queries.
• Collaborate on interdepartmental and scientific activities
• Provide support for investigator publications
• Ensure compliance with departmental and company goals
• Effectively communicates timely and relevant updates to all team members involved
• Oversee the work of junior(s) including mentoring of staff on all assigned clinical studies

Qualifications

• Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials
• Previous experience with all phases of clinical research and NDA
• Applies judgment and professional expertise independently
• Ability to prioritize and multitask
• Prior management/supervisory experience preferred.

Requirements

• Ph.D in Biostatistics or closely related discipline with a minimum of 8 years’ experience in pharmaceutical and biotech industry; or
• M.S in Biostatistics or equivalent with a minimum of 11 years’ experience in pharmaceutical and biotech industry.

Salary Range: $160,000 - $230,000

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at www.angitiabio.com

Benefits:

• Medical, dental, and vision coverage for employees and their eligible dependents
• 401(K) Retirement Plan with Company match
• Company paid Long Term Disability Coverage
• Company-paid life Insurance ADD Coverage
• Voluntary Life Insurance ADD Coverage
• Employee Assistance Program (EAP)
• Company-paid Holidays
• Vacation
• Paid Sick Leave
• Telecommunication Monthly Stipend
• Work-From-Home Equipment Reimbursement

Originally posted on Himalayas