Biostatistics Senior Manager (remote)
Summarized Purpose:
Responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, senior reviewer or project oversight on select projects. Contributes to study proposals and bids, representing the department at bid defenses. Oversees the resourcing of program of studies, or integrated summaries, develops and implements strategies to ensure optimal efficiencies around process, programming and client needs. Provides support, guidance and project leadership to junior and senior team members. Provides oversight for strategic client relationships, and/or oversight for significant client portfolios.
Essential Functions:
Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation. Serves as (or mentors others in the role of) the randomization statistician on selected projects. Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports. Manages resourcing and delivery strategy of complex books of work - ISS/ISE, submissions etc Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge. Participates in strategic client franchise leadership. Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc. Job Qualification Education and
Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8
years'). Master degree in statistics, biostatistics, mathematics or related field with 8
years experience In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
Demonstrated initiative and motivation Capable of leading complex projects Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff Strong verbal and written communication skills Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting In-depth knowledge of SAS and clinical biostatistics In-depth understanding of the drug development process and FDA regulations Capable of managing change and uncertainty to optimize positive outcomes.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, senior reviewer or project oversight on select projects. Contributes to study proposals and bids, representing the department at bid defenses. Oversees the resourcing of program of studies, or integrated summaries, develops and implements strategies to ensure optimal efficiencies around process, programming and client needs. Provides support, guidance and project leadership to junior and senior team members. Provides oversight for strategic client relationships, and/or oversight for significant client portfolios.
Essential Functions:
Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation. Serves as (or mentors others in the role of) the randomization statistician on selected projects. Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports. Manages resourcing and delivery strategy of complex books of work - ISS/ISE, submissions etc Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge. Participates in strategic client franchise leadership. Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc. Job Qualification Education and
Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8
years'). Master degree in statistics, biostatistics, mathematics or related field with 8
years experience In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
Demonstrated initiative and motivation Capable of leading complex projects Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff Strong verbal and written communication skills Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting In-depth knowledge of SAS and clinical biostatistics In-depth understanding of the drug development process and FDA regulations Capable of managing change and uncertainty to optimize positive outcomes.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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