Director, Biostatistics (RWE) - REMOTE

Proclinical is seeking a remote Director, Biostatistics for a leading biotech company.

Must be eligible to work in the US.

Job Responsibility:

• Provide statistical and methodological study expertise on assigned GMAX/RWE projects.
• Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables.
• Conduct statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs.
• Lead innovation regarding novel statistical methods and keeping up to date with best practices in RWE studies.
• Contribute to RWE protocol development and/ or statistical analysis plans, including authoring of the statistics section and reviewing of other sections by applying statistical principles.
• Provide statistical expertise for development of patient-reported outcome (PRO) measures, analysis of PRO data and assists with the interpretation of the PRO results from clinical trials and real-world studies.
• Author or oversee the development of statistical/psychometric analysis plans for clinical trials, and oversee the development of shells for tables, figures, and listings.
• Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses for RWE studies.
• Validate the results of key statistical deliverables.
• Plan and perform ad hoc and exploratory statistical analyses as needed.
• Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results.
• Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions.
• Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs.
• Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations.
• Contribute or lead standardization and process improvement efforts for Biometrics and contribute to cross-functional process improvement efforts.
• Represent company regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners.

Skills and Requirements:

• Ph.D. in statistics/biostatistics or related discipline with at least nine years of experience in the pharmaceutical or biotech industry.
• Demonstrated ability and experience in the design, analysis, and reporting of real-world studies (retrospective and prospective).
• Experience in NDAs, MAAs or other regulatory submissions.
• Experience with Patient Reported Outcomes statistical analyses (required) and psychometric analyses (desired).
• In-depth knowledge of statistical methods for clinical trials and real-world studies, including both frequentist and Bayesian approaches.
• In-depth knowledge of analysis and coding from RWE studies related to retrospective data including open and closed claims.
• In-depth understanding of study design biases and analytic methods to handle biases in real-world studies (including but not limited to choosing correct controls, matching, and propensity score).
• Moderate knowledge of psychometric analysis methods such as Classical Test Theory (CTT), Rasch analysis, Item Response Theory (IRT), Item Factor Analysis (iFA), Exploratory and Confirmatory models, Structural Equation Modelling, etc.
• Knowledge of FDA, EMA and ICH regulations and guidelines.
• Knowledge of data analytics and data handling of patient-reported outcomes (PRO) and survey data.
• Knowledge of immunology, rare diseases and/or gene therapy is desirable.
• Proficient in statistical programming (SAS is required and R, Python, Snowflake are plus).
• Understanding and knowledge of SQL coding (and application within SAS)
• Ability to concurrently lead statistical efforts for multiple projects simultaneously.
• Understanding of data standards, including SDTM and ADaM.
• Adept at overseeing statistical services provided by CRO's and/or contractors.
• Ability to work independently and act with an initiative to address issues.
• Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally across internal and external partnerships.
• Understanding and first-hand experience with intra and inter-database merges including data tokenization.

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at (+1) 305-929-0913 or p.bonilla@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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