Executive Director, Biostatistics

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY

The position provides strategic planning, oversight and execution of the biostatistics function to support an exciting/expanding portfolio of Structure’s clinical development programs. This role independently provides strategic statistical input to drug development planning, including feasibility assessments, development plans, complex/innovative study designs, novel statistical methodology, interpretations of the clinical results, regulatory submissions (IND, NDA, MAA and JNDA) and follow up. This role will work with other Biometrics functions, Data Management, Stat Programming and Data Science, to build a top biometrics function at Structure. He/She 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. This role will provide scientific leadership and work collaboratively and strategically with cross-functional teams and external partners to ensure that all data deliverables generated are accurate, timely, consistent, and executed with the highest quality standard to ensure regulatory success. This position has direct supervisory responsibilities for internal staff or external consultants.#hybrid.

Reporting to the VP, Biometrics, this leader will become a driving force of delivery and excellence, providing leadership, oversight, and technical/strategic direction to the biostatistics function.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide strategic direction and leadership to the biostatistics function, ensuring alignment with senior leadership, company goals and program objectives.

• Build, lead, and manage the biostatistics function while fostering a culture of collaboration, innovation, and excellence.

• Provides strategic input on product development strategy, including development options, statistical study design, clinical endpoint selection, sample size determination/justification, statistical analysis methodologies, randomization schedules, and data interpretation in collaboration with all team members, including programmers, data manager, medical writers and clinicians

• Prepare and review clinical data-related documentation, including clinical protocols, data management plans, CRFs, CSR, etc.

• Act as the primary contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors responsible for clinical data deliverables (e.g., cycle times for clinical database setup, UAT, edit checks, clinical data transfers, database cleaning, database locking and archival, etc.); ensure quality completion of all clinical data related deliverables

• Lead development and optimization of biometric processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices

• Evaluate and implement innovative study designs and novel statistical methodologies as appropriate across each of the therapeutic areas

• Work closely with cross-functionally colleagues (Medical, 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 selection, to ensure Structure’s conducts well designed, efficient, and cost-effective as well as statistically valid clinical trials
  • Generate and/or review randomization schedule(s) to ensure high statistical quality of clinical protocols and analyses. Ensure the 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 analysis datasets, 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 clinical study 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 and mock-TLFs.
  • Lead the study unblinding and validate TLFs post database lock
  • Lead and manage external (and/or internal) biostatistics and statistical programming resources supporting studies and programs
  • Develop Standard Operating Procedures, work instructions, guidelines, data standards, and processes as needed to govern the biostatistics group and deliverables if needed
  • 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
  • Independently complete submission of clinical data to various agencies (e.g., CDISC SDTM, ADaM, Define.xml, Reviewers Guide, via eCTD) and provide CRO oversight in ensuring deliverables meet project needs, standards, and compliance
  • Responsible for providing statistical leadership for preparation of marketing applications to FDA, EMA, or other worldwide regulatory agencies

• Keeps abreast of literature/advancements in science/medicine/technology/statistics/standards in own and related fields of the drug development programs  Perform other duties and responsibilities as assigned.

REQUIREMENTS

• A PhD in Statistics/Biostatistics and at least 15 years of clinical development and analysis and reporting experience within the biotech/pharmaceutical industry
• Proven competencies in interaction with health Authorities (FDA, EMA and PMDA) and eCTD (NDA/BLA) submissions required.
• Experiences of overseeing performance of external vendors responsible for biostatistical related deliverables.
• Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, and Study Data Standardization Plan
• Experience in leading development and optimization of Biometrics processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices
• Comprehensive knowledge of statistical methodology in design and analysis of clinical trials

Experience in implementing innovative study designs and novel statistical methodologies

• Deep knowledge in clinical development including regulatory requirements in multiple regions
• Excellent programming skills of SAS or R is strongly desirable
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in small biotech setting
• Ability to travel occasionally including overnight stay driven by business need.

Preferred Experience

• Tracking record of successive experiences of clinical trial designs/analysis and Regulatory filing in biotech/pharmaceutical industry setting and hands on statistical analysis experiences

Licenses or Certifications

• None

  Travel

5 - 10% travel required

The target salary range for this full-time role is $282,000 - $338,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.