Director Biostatistics, Clinical Operations
Director Biostatistics, Clinical Operations
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Job Description
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform peoples 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 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 whats 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 CROs; 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.
Minimum Requirements
- Ph.D. or M.S. in Statistics or related field.
- Have 10 years pharmaceutical experience in a pharmaceutical R&D environment.
- 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
AskBio 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 jobrelated 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 or sending us an email at .
Required Experience:
Director
Employment Type
Full-Time
