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Overview

Company

Original Job Post

KalVista Pharmaceuticals, Inc. · 2 days ago

Manager/Sr. Manager, Biostatistics

Cambridge, MA

Full-time

Onsite

Senior Level

3+ years exp

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Responsibilities

Provide statistical input into the design and analysis of clinical trials, including protocol development, sample size determination, and statistical analysis plans

Serve as the lead statistician on multiple projects, ensuring the appropriate application of statistical methodologies

Perform complex statistical analyses and interpret results in the context of clinical research objectives

Provide specifications and review statistical reports, including tables, listings, and figures for clinical study reports, publications, and presentations

Collaborate with cross-functional teams, including clinical researchers, data managers, medical writers, and regulatory affairs, to ensure the successful execution of clinical studies

Communicate statistical concepts and results to non-statistical stakeholders in a clear and concise manner

Conduct quality control checks on statistical deliverables to ensure accuracy and consistency

Provide statistical support for regulatory submissions, including the preparation of summary documents and responses to regulatory agency queries

Stay updated on regulatory guidelines and ensure adherence to relevant standards (e.g., ICH, FDA, EMA)

Participate in the development and implementation of departmental processes and standards

Qualification

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BiostatisticsStatistical ProgrammingClinical TrialsRegulatory RequirementsProject ManagementProblem-SolvingCommunicationTeamworkRegulatory SubmissionsInteractions with Regulatory Agencies

Required

PhD or Master’s degree in Biostatistics, Statistics, or a related field

Minimum of 3-6 years of experience in biostatistics within the pharmaceutical, biotechnology, or healthcare industry

Proficiency in statistical programming languages (e.g., SAS, R) and familiarity with clinical trial databases

Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., ICH, FDA, EMA)

Excellent written and verbal communication skills, with the ability to present complex statistical concepts to non-statistical audiences

Strong analytical and problem-solving abilities, with attention to detail and accuracy

Proven ability to lead and manage multiple projects simultaneously, while working effectively in a team-oriented environment

Preferred

Experience in regulatory submissions and interactions with regulatory agencies preferred

Company

KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals is a biopharmaceutical company developing oral medicines designed to empower people to enjoy everyday life beyond the challenge of their disease.

Founded in 2011

Cambridge, Massachusetts, USA

51-200 employees