[Remote] Director Biostatistics, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. AskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines. The Director, Biostatistics, will provide technical leadership and operational oversight for clinical strategies, collaborating with cross-functional teams and ensuring high quality deliverables in biostatistics for drug development.

Responsibilities

• Responsible for all deliverables related 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, endpoint selection, and power and sample size assessment
• Responsible for SAP, 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 commercial 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 related 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 SAS 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 outside 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 related field.

Company Overview

Company H1B Sponsorship