Principal Biostatistician

Precision For Medicine; Elche; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

A leading company in clinical development is seeking a Biostatistician to provide statistical support across all clinical phases. This mid-senior level position requires a strong background in statistics, extensive experience with SAS, and the capability to lead statistical activities. You will work closely with project teams and sponsors, ensuring high-quality statistical analyses and compliance with industry standards. Ideal candidates will possess a Master's or PhD in a related field and have experience in Oncology or rare diseases.

Formación

• Master's or PhD in Statistics/Biostatistics with 7-10 years experience.
• Broad knowledge of statistical concepts and FDA guidelines required.
• Experience with Oncology and rare diseases is preferred.

Responsabilidades

• Develop and review statistical methods for clinical study protocols.
• Author and review statistical analysis plans and reports.
• Generate analysis datasets and perform quality control checks.

Conocimientos

SAS programming

Statistical analysis

Statistical methods

Problem-solving

Communication

Interpersonal skills

Educación

Master's degree in Statistics

PhD in Statistics

Herramientas

SAS

Descripción del empleo

1 week ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Position Summary :

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 including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, 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 :

• 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

Qualifications : Minimum Required :

• 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

Other Required :

• 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

Preferred :

• 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)

Skills :

• Mastery of statistical principles underlying clinical trials
• Mastery of SAS programming skills and familiarity with other packages
• Outstanding statistical 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
• 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.)

Any data provided as a part of this application will be stored in accordance with our Privacy Policy.For CA applicants, please also refer to ourCA Privacy Notice.

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.

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

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Research, Analyst, and Information Technology
• Industries Technology, Information and Internet

Referrals increase your chances of interviewing at Precision For Medicine by 2x

Get notified about new Biostatistician jobs in Spain .

DATA ANALYST / ENGINEER POWER BI / INGLES C1 / VALENCIA HIBRIDO Business Analyst & Data Annotator (for ML)

Greater Madrid Metropolitan Area 1 day ago

Madrid, Community of Madrid, Spain 3 weeks ago

Madrid, Community of Madrid, Spain 6 months ago

Madrid, Community of Madrid, Spain 2 weeks ago

Rev-celerator Graduate Programme 2026 : Data Analyst Digital Data Analyst - Spanish Speakers in Spain Data Analyst (Full remote within Spain) (Disability certificate 33 required)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr