Manager, Biostatistics – Homebased

Responsible for leading the biostatistics efforts for specific projects and studies, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs.

In addition, responsible for managing resources within the Biostatistics and Statistical Programming department.

As part of the Biostatistics team, this person will also provide technical expertise to the development of programming standards and procedures.

Essential functions of the job include but are not limited to

• Manage biostatistician and/or statistical programmer employees within Biostatistics functional area.
• Develop and maintain departmental procedures and standards.
• Assist with project forecasting and resourcing needs through a combination of internal and external resources.
• Hire, train, guide career growth, and provide development opportunities for Biostatisticians.
• Provide oversight for assigned projects.
• Provide technical oversight and leadership in the areas of analysis and reporting.
• Generate randomization schedules.
• Provide sample size calculations and assist in protocol development.
• Provide input into development of case report forms (CRFs).
• Author statistical analysis plans, including development of table and listing shells.
• Review statistical analysis plans written by other Biostatisticians.
• Write analysis plans for eCTD submissions (eg, ISS and ISE)
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
• Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
• Review output across programs to ensure consistency.
• Prepare statistical sections of clinical study reports.
• Interact directly with clients.
• Assist in SOP creation/review and associated forms and templates.
• Participate in the development and/or maintenance of departmental procedures and standards

Qualifications

Minimum Required:

• Masters degree or equivalent in Statistics, Biostatistics, or related field with 5+ years experience

Other required:

• Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Experience with SAS
• Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials

Preferred:

• Experience with Oncology and rare diseases
• Experience with late phase and/or submissions

Skills:

• Understanding of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
• Understanding of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.
• Excellent problem solving skills
• Excellent presentation skills

Competencies:

• Sound judgment/decision making
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Service oriented, accountable and flexible
• Competency in written and spoken English
• Follow applicable regulations, including FDA, ICH, and Precision Policies and Procedures
• At all times to promote the image of Precision, acting as an ambassador to the Company
• Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)