Frederick, United States

Senior Biostatistician

Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.

Essential functions of the job include but are not limited to:

Generate and/or verify randomization schedules
Review statistical methods of the clinical study protocol
Provide and/or verify sample size calculations
Provide input into development of case report forms (CRFs)
Author statistical analysis plans, including development of table, figure and listing shells. • Review statistical analysis plans written by other biostatisticians
Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
Provide programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
Perform statistical consulting tasks with some senior oversight
Review output across programs to ensure consistency.
Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician
Review statistical sections of clinical study reports
Work directly with sponsors, project managers, and external vendors on statistics-related project components
Interact directly with study team
Interact directly with sponsors
Lead all statistical activities for study within timelines
Assist with budget health review on projects and review monthly invoices
Perform oversight responsibilities on projects for new biostatisticians
Assist with budget development and present at bid defense meetings
Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.)
Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope
Other duties as assigned.

Qualifications:

Minimum Required:

Master's degree or equivalent in Statistics, Biostatistics, or related field with 4+ years experience; PhD degree in Statistics, Biostatistics, or related field with 2+ years experience

Other Required:

Experience with SAS
Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
Knowledge of advanced clinical trial design concepts and advanced statistical methodologies

Preferred:

Experience with Oncology and rare diseases
Experience with late phase and/or submissions
Experience in consulting with clients on study design

#LI-Remote

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$1—$1 USD

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