Associate Director, Biostatistics

Clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Company is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. Currently, the company is seeking an Associate Director, Biostatistics to join the statistical team to provide study level support cross-functional settings including participating in study design, sample size calculations, supervision of CRO, reviewing statistical analysis plan, TFL shells, CRF, DSMB charter, TFL outputs, abstracts, CSR, IND, ISS, ISE, managing study timelines. Some hands-on ad-hoc analyses may be required outside of the CRO provided outputs.

Responsibilities

• Responsible for statistical input to clinical development plans, clinical study concepts and protocols, case report forms, clinical study reports, regulatory documents, scientific publications, internal and external meetings, and presentations.
• Accountable for development, implementation and execution of statistical analysis plans that support clinical development plans and clinical protocols, to ensure statistical integrity, adequacy and accuracy.
• Accountable for production of biostatistics deliverables (planned, post-hoc, and/or exploratory analyses) by providing oversight of the work performed by CROs, managing external Biostatistics and Statistical Programming consultants, as needed, or performing the work themselves, to ensure timeliness and quality of analysis data and statistical outputs.
• Contribute to developing Departmental standards (CRF design, ADaM datasets, TFL Mocks).
• Responsible for development and interpretation of topline study results in close collaboration with the clinical and cross-functional teams.
• Participate in global regulatory interactions including filings, written, oral and face to face interactions, as needed.
• Lead one or more department initiatives.
• Ensure all biostatistics activities comply with industry norms, health authority regulations, ICH/GCP guidelines and company SOPs.

Qualifications

• PhD or MS in statistics or mathematics.
• At least 5-7 years of pharma / biotech industry experience. Rare disease or Oncology experience is a plus.
• Comprehensive knowledge of clinical trials methodology, and statistical software packages. Proficiency in SAS required, and knowledge of other languages (R) is a plus.
• Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistics and drug development.
• Proven experience within both early and late-stage development phases, including selection of relevant clinical study endpoints and outcome measures.
• Preferred experience managing external statistical and programming resources.
• Proven track record of innovative approaches such as adaptive clinical trial design.
• Excellent interpretation and presentation skills and ability to communicate statistical concepts and data to non-statisticians.
• Advanced knowledge of CDISC requirements for SDTM and ADaM.
• Knowledge of clinical data management systems.
• Able to collaborate effectively with internal, cross-functional, and external study teams to meet project timelines.
• Excellent organizational skills and attention to detail. 
• Able to set priorities and juggle multiple projects and demands.
• Able to work independently while exercising initiative, flexibility, and sound judgment.
• Ability to operate in alignment with company's values.