Associate Director, Biostatistics

October 31

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Apellis Pharmaceuticals

WebsiteLinkedInAll Job Openings

Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000 employees

Founded 2009

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• The Associate Director of Biostatistics acts as statistical lead for multiple clinical studies and/or a clinical development program. • Provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. • Participates in regulatory interactions and submissions to the FDA and other regulatory agencies. • Contributes to the biometrics effort across the different programs to identify, develop and implement departmental standards, applications, processes, and training. • Contribute in study level tasks from statistics perspective, including study design and sample size determination. • Author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files. • Develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings. • Lead in product level tasks including regulatory interactions and filing and ensure statistical integrity. • Work collaboratively with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting. • Oversee statistical work by CRO and ensure quality deliverables with respect to key performance indicators, metrics, and program level deliverables and timelines. • Translate statistical thinking into a strategic input to advance the clinical program. • Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve efficiency and sensitivity of study results. • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements. • Lead in developing department standards and research in advanced statistical methodologies. • Author/review regulatory documents or scientific publications. • Contribute to project budget/resource planning, re-forecasting, and program milestones.

Requirements

• PhD in Statistics, Biostatistics or Mathematics with a minimum of 5 years (minimum 8 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry. • Lead in NDA/BLA/MAA activities from a statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections. • Adept at outsourcing and managing biostatistical services provided by CRO’s and contractors. • Experienced as product lead statistician and contribute to strategy discussion in cross-functional settings; Experienced in managing multiple products and studies and being able to prioritize. • Experienced in study level work including authoring SAP and TFL specification. • Develop SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays. • Lead development of department SOPs. • Familiar with ICH guideline, FDA/EMA/other regulatory authority guidance. • Solid understanding of mathematical and statistical principles; Experience in statistical methods (longitudinal data analyses, Bayesian method, adaptive design, Simulations) is preferred. • Excellent communication and interpersonal skills, with the ability to translate statistical concepts to program strategies. • Detailed-oriented with organization, problem-solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline. • Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies. • Positive and collaborative attitude.

Benefits

• health insurance with full premium coverage • 401K with company match • paid time off (PTO) • long- term disability insurance • life insurance and more!