Director Biostatistics - REMOTE

Proclinical is seeking to hire a remote Director Biostatistics. This individual will act independently as the statistics subject matter expert for all clinical development programs and studies, while ensuring adherence to all regulatory requirements.

Job Responsibilities:

• Extensive collaboration with integrated clinical teams to design studies, develop statistical analysis plans, and draft statistical reports / manuscripts for clinical studies in all phases for FDA/MAA, as well as for other global regulatory authorities
• Provide strategic and statistical input to clinical programs and clinical study teams, as well as advisory board or expert meetings
• Actively contribute to what and how data are collected, be familiar with CDISC data structure, formatting and documentation standards for clinical studies, as well as integrated safety and efficacy datasets
• Review documents related to clinical data management, including (e)CRFs, EDC, eSource/eCOA/ePRO and data management validation plans and their deployment
• Prepare randomization specifications and generate or oversee the setup of randomization processes and systems, including enrichment trial designs
• Plan, program and execute sample size and assumptions calculations and simulations for conventional, adaptive and enrichment trial designs, reflecting the actual methodology planned for the study evaluation, including statistical model, missing data and multiplicity handling, as well as sensitivity analyses
• Design, develop, modify, document and evaluate the technical data processes, systems and infrastructure to expedite and evaluate analysis and reporting of clinical studies
• Ensure accuracy, precision, efficiency, robustness in statistical planning, study design, statistical analysis, interpretation, reporting, and presentation of clinical study results
• Evaluate and interpret clinical trial data, write up reports, prepare slides and present results to internal and external stakeholders including regulatory agencies
• Assist in drafting and review of clinical study reports and statistical methodology and results sections of documents prepared for scientific communication (i.e., reports, manuscripts, posters, abstracts), including posting of results in public study registries
• Contribute to the selection, information, oversight and evaluation of expert consultants, contractors, CROs and other partners providing statistical services
• Participate in multi-disciplinary meetings and teleconferences and provide consulting, interpretive, and analytical support
• Identify and plan statistical tasks, timelines, resources and account for critical dependencies and resources in order to estimate, agree and ensure that statistical work meets deadline commitments and quality standards in a timely manner
• Lead projects by managing statistical tasks, resources, timelines and budgets as well as act as point of contact for internal and external teams including consultants, contractors, CROs and other vendors
• Contribute to the definition and oversight of the setup, methodology, tools decision rules, support and implementation of DMCs and ability to direct, mentor junior statisticians, data managers, and programmers
• Take an active role in task forces or process-improvement groups and assist in providing guidance related to biostatistics, programming, and data management
• Maintain exhaustive program and clinical trial documentation, including design, execution, evaluation, review, QC, tracking information, as well as internal and external communications
• Perform peer review of other statisticians' work; Perform QC of analysis datasets, data displays for efficacy and safety variables

Skills and Requirements:

• A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 8 years of relevant clinical biostatistics experience in pharma, biotech or medical device industry -OR- a Master's degree and a minimum of 10 years of relevant industry experience is required
• Experience of rare disease clinical development and NDA is highly preferred; Comprehensive knowledge of statistical theory and methods
• Demonstrated ability to apply statistical, programming, and data management knowledge to clinical studies and other supportive tasks
• Expertise in SAS and R programming for data management, conversion, review and visualization, statistical analysis, tabulation, listing and graphs of clinical trial data
• Excellent verbal and written communication skills; Leadership and team-ability with effective intercultural competences, diplomacy, negotiation and communication
• Self-management skills with the ability to take initiatives, develop and evaluate alternative scenarios and options, and present them effectively to the colleagues and leadership of the company
• Proficiency in MS Word, Excel, and PowerPoint software programs
• Excellent problem-solving and strategic-thinking skills
• Sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.)
• Excellent written and oral communication and presentation skills
• Ability to identify and address issues proactively in a timely manner
• Ability to make appropriate, rational and well-justified decisions in ambiguous situations with incomplete or uncertain information
• Ability to prioritize tasks and direct team accordingly

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or m.hermiz@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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