[Remote] Director Biostatistics, Clinical Operations
Note: The job is a remote job and is open to candidates in USA. reputed company. is a fully integrated gene therapy company dedicated to developing life-saving medicines. The Director, Biostatistics, will provide technical leadership and operational reputed company for clinical strategies, collaborating with cross-functional teams and ensuring high quality deliverables in biostatistics for drug development.
Responsibilities
- Responsible for reputed company deliverables reputed company to statistical content. Provides guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables
- Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact
- Oversees the biostatistics function in CRO’s; manages scope of work and relationships with other external statistician consultants as needed
- Manages resources, sets priorities, and ensures consistency and adherence to standards
- Collaborates on protocol development including study design, reputed company selection, and power and sample size assessment
- Responsible for reputed company, data analysis and reporting (CSR). Supports DMC charter and meeting preparation
- Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities
- Supports regulatory submission and interaction, i.e, and IND/BLA filings and supports potential partnering requests
- Becomes an integral member of cross-functional project teams, provides statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentations
- Develops solutions to statistical and data analysis issues for clinical, regulatory, and reputed company teams. Communicates solutions cross-functionally
- Contributes to creation/maintenance of, and provides training on statistical topics, and departmental SOPs and general standardization efforts
- Maintains currency of new developments in statistics, drug development, and regulatory guidance
- Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as needed
- Assists with the Business Development activities at key conferences and industry meetings
- Supports scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion Leaders
- Presents at industry conferences representing AskBio
- Participates in vendor evaluation, selection, and management
Skills
- Ph.D. or M.S. in Statistics or reputed company field
- 10+ years pharmaceutical experience in a pharmaceutical R&D environment
- Knowledge of Heart Failure and Cardiovascular programs
- Strong knowledge of design of experiments, clinical trial design concepts, or CMC statistics, drug regulation, and experience in the management of the statistical function
- Experience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy preferred
- Extensive experience with reputed company and/or R
- Excellent communication skills
- Experience in CRO selection, contracting and management
- Excellent leadership and interpersonal skills, ability to build credibility and trust inside and reputed company the Company
- Experience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy
Education Requirements
- Ph.D. or M.S. in Statistics or reputed company field.
Company Overview
Company H1B Sponsorship