Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
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.
About the role
The Director, Biostatistics, reporting to the Vice President, Biostatistics, Clinical Development, 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. This position will work in close collaboration with the cross functional teams responsible for studies across all phases of drug development. The position provides guidance and management to statisticians to ensure high quality and timely deliverables. The position 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.
Responsibilities & Accountabilities
Responsible for all deliverables related to statistical content including providing guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables.
Advise and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact.
Oversee the biostatistics function in CRO’s; manages scope of work and relationships with other external statistician consultants as needed.
Manage resources, sets priorities, and ensures consistency and adherence to standards.
Collaborate 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.
Support regulatory submission and interaction, and IND/BLA filings and supports potential partnering requests.
Become 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.
Develop solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally.
Contribute to creation/maintenance of, and provides training on statistical topics, and departmental SOPs and general standardization efforts.
Maintain currency of new developments in statistics, drug development, and regulatory guidance.
Participate in due diligence evaluation of design and clinical trial data of external partnerships opportunities.
Assist with the Business Development activities at key conferences and industry meetings.
Support scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion Leaders.
Present at industry conferences representing AskBio.
Participate in vendor evaluation, selection, and management.
Minimum Requirements:
M.S in Statistics or related field is required; PhD is preferred
10+ years’ pharmaceutical experience in a pharmaceutical R&D environment.
Working knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional. Experience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy.
Strong leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
Extensive experience with SAS and/or R.
Excellent verbal and written communication skills.
Experience in CRO selection, contracting and management.
Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.
Go Premium: Access the World's Largest Selection of Remote Jobs!