Senior Director of Biostatistics

Company: Dicerna
Location: Cambridge
Posted on: September 15, 2020

Job Description:

The Senior Director of Biostatistics will report to the Vice President of Biometrics and Data Management. The Senior Director of Biostatistics will be the statistical expert in at least one of Dicerna’s drug development programs. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. The person will lead and oversee biometric focused regulatory interactions and submissions to the FDA and other regulatory agencies; Additional mentoring and delegation of tasks will be required as appropriate. The person will participate in the development and implementation departmental standards, applications, processes, and training.

Key Responsibilities

Contribute in study level tasks from statistics perspective, including but not limiting to: 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; contribute strategically to the supporting projects from the statistics perspective.

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 the 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.

Ability to potentially manage lower level statisticians and programming

Author/review regulatory documents or scientific publications.

Contribute to project budget/resource planning, re-forecasting, and program milestones.

Qualifications

PhD in Statistics, Biostatistics or Mathematics with a minimum 12 years’ experience (or MS with minimum 15 years’ experience) in the pharmaceutical/biotech/device industry.

Minimum of at least 3 years’ supervisory and mentoring experience.

Excellent writing, communication and interpersonal skills, with the ability to translate statistical concepts to program strategy.

Strong ability to prioritize tasks to statistical and programming resources.

Prior experience 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.

Prior experience 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) is preferred.

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/or R; knowledge and experience in CDISC requirements including SDTM, ADaM, and controlled terminologies.

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Keywords: Dicerna, Cambridge , Senior Director of Biostatistics, Other , Cambridge, Massachusetts