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Invivyd · 3 months ago

Director, Biostatistics

New Haven, CT (Northeast Preferred)

Full-time

Onsite

Director/Executive

10+ years exp

Invivyd, Inc. is dedicated to delivering protection from serious viral infectious diseases, starting with SARS-CoV-2. The Director of Biostatistics will lead statistical science efforts in clinical development, ensuring adherence to standards and providing statistical support to clinical research personnel.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Applies statistical expertise to ensure innovative clinical trial designs, analysis methods and data displays; accountable to deliver high quality writing and supervision of statistical analysis plans

Uses advanced statistical techniques to analyze clinical study data

Performs clinical trial simulations to optimize clinical trial designs

Ensures scientific integrity of the statistical methodology applied to clinical trials

Provides input to development programs including filing strategies worldwide, study design, analytic methods, and endpoints that meet both regulatory and scientific requirements

Collaborates with other functional areas within the company (clinical data management, clinical research, global drug safety, regulatory and project management)

Makes presentations and may represent biostatistics to therapeutic leads, senior management, external collaborators, FDA meetings and medical and statistical meetings

Provides statistical direction and technical oversight for projects requiring statistical input

Supports the presentation and publication of clinical trial results and contribution to advances on statistical topics and presents at scientific conferences

Clarifies project deliverables and timelines for statistical analysis and reporting and ensure that they are met

Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics

Qualification

In statisticsSASR programmingClinical trial processesRegulatory submission experienceStatistical analysis plansStatistical directionData analysisCollaboration skills

Required

PhD in statistics, biostatistics or equivalent area with 10+ years biopharmaceutical industry experience required

MS degree in related discipline with extensive industry and leadership experience (14+ years) can be considered

Scientific programming experience with SAS or R

Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)

Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used

Ability to travel to New Haven 1x a month