Director Biostatistics, Clinical Operations

Director Biostatistics, Clinical Operations page is loaded## Director Biostatistics, Clinical Operations remote type:
Remote locations:
Remote US:
UK Remote time type:
Full time posted on:
Posted 12 Days Agojob requisition :
R25-64

Ask Bio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

Ask Bio’s gene therapy platform includes Pro
10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
** Our vision:
** Pioneering science to create transformative molecular medicines.
** Our mission:
** Lead innovative science and drive clinical outcomes to transform people's lives.
** Our principles:
*** Advance innovative science by pushing boundaries.
* Bring transformative therapeutics to patients in need.
* Provide an environment for employees to reach their fullest potential.
** Our values:
*** Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
* Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
* Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
* Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
* Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
** Position Summary
** The Director, Biostatistics, provides technical leadership and operational oversight for the development of clinical strategies, the design, implementation and reporting of non-clinical, CMC, and clinical development programs and associated studies and clinical trials. He/she participates in close collaboration with the cross functional teams responsible for studies across all phases of drug development. He/she provides guidance and management to statisticians to ensure high quality and timely deliverables.

He/she also supports regulatory interactions and serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally. This role reports to VP, Biostatistics, Clinical Development.
** Job 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…