Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
Tailor your resume to this Principal Biostatistician role.
Rezi rewrites your resume against Precision Medicine Group's job description. Free.
Tailor your resume to this Principal Biostatistician role.
Rezi rewrites your resume against Precision Medicine Group's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Principal Biostatistician posting at Precision Medicine Group — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Principal Biostatistician posting at Precision Medicine Group — free, in seconds.
About the Role
Provides statistical support for all phases of clinical development, including writing and reviewing statistical sections of protocols, developing analysis plans, conducting analyses, and presenting results. This role involves developing SAS programs for data presentation and analysis.
Responsibilities
- Generate and/or verify randomization schedules
- Develop and review statistical methods of the clinical study protocol including complex study designs
- Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design
- Provide input into development of case report forms (CRFs)
- Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase
- 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 or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives
- 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
- Independently perform budget health review on projects and review monthly invoices
- Perform oversight responsibilities on projects for other 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
Requirements
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
- Experience with SAS
- Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
- Experience with Oncology and rare diseases
- Broad experience with late phase and/or submissions
- Experience in consulting with clients on study design
- Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data)
- Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Skills
- Mastery of statistical principles underlying clinical trials
- Mastery of SAS programming skills and familiarity with other packages
- Outstanding statistical skills
- Excellent consultative skills
- 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
- Sound judgment/decision making
- Ability to establish and teach others to maintain effective working relationships with coworkers, managers and clients
- Service oriented, accountable and flexible
- Competency in written and spoken English
- Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures
Experience Level
- 10+ years experience (Master's degree)
- 7+ years experience (PhD degree)
Education Level
- Master's degree or equivalent in Statistics, Biostatistics, or related field
- PhD degree in Statistics, Biostatistics, or related field
About the Company
- Precision Medicine Group is an Equal Opportunity Employer.
Equal Opportunity
- Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
- If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.