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Biostatistician II Bucharest

Precision for Medicine

Precision for Medicine Bucharest Romania

2 months ago

Due to continued growth, Precision for Medicine are hiring! We have open opportunities for an experienced Biostatistician working in Clinical Research.

We are looking for a Biostatistician II to join our friendly European team. Great opportunity with continued development options in the role.

We offer flexible location options in Europe including: UK, France, Spain, Italy, Poland, Hungary, Serbia, Romania, Slovakia. This is a remote based position.

Position Summary:

To provide statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing 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 randomization schedules
• Assist with statistical methods review of the clinical study protocol... under close supervision of senior biostatistician or above
• 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
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide programming support and assist with statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Assist with statistical consulting tasks under close supervision of senior lead biostatistician or above
• Review output across programs to ensure consistency under close supervision of senior biostatistician
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician under close supervision of senior 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
• Assist with completion of statistical activities for study within timelines
• Provide units for development of monthly project invoices
• Train and mentor new biostatisticians
• Opportunities to assist with bid defense meetings

Qualifications:

Minimum Required:

• Master's degree / PhD or equivalent in Statistics, Biostatistics, or related field with strong relevant 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.)

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy.

Precision Medicine Group is an Equal Opportunity Employer. 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. © 2020 Precision Medicine Group, LLC

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 [email protected].
Any data provided as a part of this application will be stored in accordance with our Privacy Policy.

Precision Medicine Group is an Equal Opportunity Employer. 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. © 2020 Precision Medicine Group, LLC

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 [email protected]
Bucharest Romania

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