Director of Biostatistics

Company Profile

We are Aspyrian Therapeutics Inc., a privately funded, clinical stage, Biotechnology Company located in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.

We are supported by visionary investors that have the commitment to build a long-term company that integrates research, development, and commercialization of cutting-edge cancer therapies with the aim to transform cancer treatments. Our mission is "CONQUERING Cancer. For LIFE".

Position Summary

The Director of Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Independently provides strategic statistical input to drug development planning, including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions, and follow up. Contributes to establishing and driving strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Medical, Clinical Scientists, Data Management, Clinical Operations, Safety, and Regulatory teams providing overall statistical leadership, direction, and consulting as it relates to the design, analysis, and reporting of Aspyrian Therapeutics clinical trials in support of all Phases of clinical development and regulatory submission programs. Represents biostatistics in core project team meetings on operational and strategic decision-making related to assigned projects. This individual is also accountable for the production of biostatistics deliverables by providing oversight of the work performed by CROs, managing external (and/or internal) biostatistics and statistical programming resources, or performing the work themselves.

The Director of Biostatistics will report to the Chief Medical Officer and work closely with the Clinical team.

Key Duties and Responsibilities

Act as the primary contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors
Work closely with colleagues (Medical, Clinical Scientists, Data Management, Statistical Programmers, Medical Writing, Safety, Clinical Operations, and Regulatory teams) to:

Review protocols and prepare statistical methods section(s), including sample size estimation and clinical endpoint assessments, to ensure Aspyrian Therapeutics conducts well designed, efficient, cost-effective as well as statistically valid clinical trials

Generate and/or review randomization schedule(s) to ensure there are no errors and protocol requirements are met. Perform ongoing monitoring of actual randomization scheme applied by IVRS/IWRS

Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed

Prepares and/or reviews detailed Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of a formal statistical analysis report

Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications

Coordinate and lead team review and consolidation of comments for SAP, mock-TLFs, and unblinded populated TLFs post database lock

Ensures proper closeout and archiving of study related materials, i.e. randomization lists, datasets, programs, specifications, macros, etc.

Lead and manage external (and/or internal) biostatistics and statistical programming resources supporting studies and programs for Aspyrian Therapeutics
Build in-house statistical and programming department to support those activities as Aspyrian Therapeutics expands and grows
Develop Standard Operating Procedures, work instructions, guidelines, data standards, and processes as needed to govern the biostatistics group and deliverables
Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions
Leverage standardization to maximize global data integration and interpretability
Without guidance, retrieve and understand regulatory requirements regarding submission of clinical data to various agencies (e.g., CDISC SDTM, ADaM, Define.xml, Reviewer's Guide, via eCTD) and provide CRO oversight in ensuring deliverables meet project needs, standards, and expectations
Responsible for providing statistical leadership for preparation of marketing applications (BLA) to FDA, EMA, PMDA, or other worldwide regulatory agencies
Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design, and/or Bayesian approaches)
Keeps abreast of literature/advancements in science/medicine/technology/statistics/standards in own and related fields of the drug development programs

Desired Education, Skills, and Experience

A PhD in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 13 years of relevant pharmaceutical experience
Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design
Experience with regulatory requirements relating to clinical development of drugs
BLA experience with combination drug/device a plus and eCTD submissions preferred
Excellent knowledge of major statistical software programs including SAS
Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewer's Guide, Validation Rules, and Study Data Standardization Plan
Excellent verbal and written communication skills, and excellent inter-personal skills
The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize