Associate Director Biostatistics - Remote

Contact: Mark Maurer - mmaurer@penfieldsearch.com
Primary Duties: The Lead Statistician will be responsible for strategic statistical and ‘hands on’ day to day support for several studies in support of company's clinical programs. This Lead will act as the lead statistician for more than one study, contribute and collaborate on study/project teams, develop the statistical design/strategy and statistical analysis plans, conduct exploratory analyses using R/SAS, design the tables, listings and figures for statistical reporting, work closely with the programming team to define ADaM specifications and review ADaM datasets, and support responses to regulatory questions. This role will contribute to Protocols, data reporting (TFLS) for CSR/DSUR/IB reporting, regulatory activities and safety assessment. This role will be a core member of the Study and Clinical Project teams, key partner with R&D colleagues and collaborate across Biometrics and RWE functions to progress company's portfolio of clinical stage gene therapies.
Responsibilities:

• Lead the statistical strategy for more than one study and participate as a core member on study/clinical project teams.
• Be accountable and responsible for the statistical design, analysis, reporting (including development of ADaM specifications/datasets) and interpretation of Phase 1-4 clinical trials including integrated analyses across trials
• Initiate, drive and implement novel methods and innovative trial designs.
• Provide statistical input into protocol and case report form (CRF) development (e.g., trial design, sample size estimation, statistical methods for protocols, edit checks for clinical trial data)
• Participate in regulatory (e.g., pre-IND, NDA) activities including authoring of statistical sections and participating in regulatory meetings/written responses.
• Contribute to planning and execution of exploratory analyses, data visualization and statistical consultation on cross-functional teams.
• Collaborate cross-functionally (e.g. data management, programming, safety, clinical, etc) to ensure timeliness and quality for statistical deliverables.
• Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings.
• Write statistical analysis plans. Design and develop tables, listings and figures (mock TLFs). Partner with programming on analysis datasets and review of TLFs.
• Quality assure and validate statistical outputs (TFLs) and develop/review ADaM specifications and datasets, interpret and clearly communicate statistical results and concepts to non-statisticians.
• Provide statistical support and outputs for conference presentations, manuscripts, CSRs, DMCs, etc.
• Develop/Write statistical standard operating procedures (SOPs) and input into general standardization efforts (e.g., CDISC, TFLs, eCRFs).
• Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

Education and Experience Requirements:

• PhD in Biostatistics or Statistics with ≥ 6 years of pharmaceutical or CRO industry experience (MS candidates with significant related experience may be considered)
• Experience reporting Phase 1-3 clinical trials data in CSRs to CDISC standards.
• Experience supporting regulatory efforts.
• Deep and broad statistical expertise in methodologies such as Mixed Models, Bayesian approaches, Interim Analyses including Futility, Modelling and Simulation methods, and in SAS, R.
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
• Excellent verbal and written communications skills, strong presentation skills, able to translate statistical concepts to non statisticians.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.
• Experience with rare diseases and/or gene therapy development preferred
• Extensive SAS and R programming required.
• Extensive experience reporting clinical studies to CDISC standards
• Expertise and experience in ADaM specifications and datasets
• Experience writing statistical analysis plans and mock TFLs for clinical study reporting.
• Experience working on clinical study teams and project teams to design studies including sample size calculations.
• Experience supporting DSURs, IBs and DMCs.