Job Description

Manager, Biostatistics
remote from anywhere in the U.S. or Canada
full-time or Contract

JOB OVERVIEW
The Manager, Biostatistics is responsible for the departmental efforts in developing and implementing innovative statistical methods in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. Additional responsibilities include providing leadership for Biometrics project teams and study deliverables and being a key contributor to clinical studies for statistical concepts.

RESPONSIBILITIES

• Perform/oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to Sponsor, regulatory authorities, and the scientific community.
• Create/provide oversight of statistical outputs and other documents as required.
• Provide statistical and methodological consultation on special statistical methodology or statistical, scientific, and regulatory issues.
• Perform or oversee power/sample size calculations to determine appropriate trial size.
• Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements.
• Write and/or review statistical analysis plans with table shells where appropriate.
• Development and validation of programs in one or more of the R programming language, Python, and/or SAS.
• Review protocol/CIP, CRF, data management plan and edit specifications
• Develop, review, and approve randomization specification and randomization code
• Prepare and review data displays.
• Perform quality control of safety, efficacy, ISS, and ISE data displays and data integration.
• Provide/review/approve specifications for structure, content, and algorithms for efficacy ADaM datasets.
• Prepare and review statistical report, statistical section of the CSR, and DSMB/DMC Charter
• Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by statistical programmers.
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
• Key contributor in project planning.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
• Manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables, and processes.
• Develop and assist in maintenance of department tools, templates, guidelines, SOPs, work instructions, training, and process documentation.

• Master\'s degree in Statistics, Biostatistics, or related discipline.
• 10+ with Master\'s/7+ with PhD years\' experience in statistical or biostatistical analysis supporting clinical trial operations for drug development in the pharma/biotech industry
• Proficient working knowledge of SAS and/or R programming languages
• Proficiency in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data, and survival analysis techniques
• Study Lead experience working with cross-functional teams. Experience leading global teams a plus.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Good SAS programming skills for QC\'ing critical outputs, efficacy/safety tables and working closely with programmers.
• Solid understanding and implementation of CDISC requirement for regulatory submissions.
• Adept in ADaM specifications generation and review of datasets.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Energized self-starter
• Excellent organizational skills
• Excellent communication skills, verbal and written
• Exceptional attention to detail
• Strong interpersonal skills to work within a cross-functional team
• Excellent problem-solving skills
• Effective decision maker - able to exercise good judgment and take appropriate action independently
• Flexible, team player
• Proven ability to organize and effectively prioritize workload and deliverables

Atorus