Senior Biostatistician

Experteer Italy; Veneto; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the biostatistics field is seeking a Senior Statistician to provide essential statistical input for clinical trials. This role requires a strong background in biostatistics, proficiency in SAS programming, and a commitment to quality and teamwork. The right candidate will play a pivotal role in guiding studies from inception to completion, ensuring robust methodologies are applied across various therapeutic areas.

Competenze

• At least 3 years of experience in Biostatistics.
• Proficient in SAS Programming and statistical methodologies.
• Strong problem solving and commercial writing skills.

Mansioni

• Prepare Statistical Analysis Plans and supervise biostatistical tasks.
• Conduct sample size calculations and review statistical analyses.
• Train staff on statistical methodologies.

Conoscenze

SAS Programming

Statistical methodology skills

Statistical Principles for Clinical Trials

Problem Solving Skills

Commercial Writing Skills

Formazione

Bachelor of Arts (BA) : Statistics

Strumenti

MS Office Suite

Descrizione del lavoro

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values : be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Senior Statistician provides statistical and methodological input necessary to plan, conduct, analyse and interpret results for studies in Phases I-IV and across studies for submission in a variety of therapeutic areas and in both medical device and drug settings.

KEY RESPONSABILITIES

Carries out tasks assigned within the timelines and the standards of quality

Provides supervisions on tasks carried out by biostatisticians

Preparation of Statistical Analysis Plans

Writing of the statistical methodology and results sections of reports

Provides statistical input to the design and review of Protocols and Case Report Forms

Prepares and performs trainings of other staff and clients on statistical methodology and statistical principles

Writes and reviews the statistical methodology and results sections of reports

Review of Statistical analysis (tables, figures and listings) and specifications of clinical trials

Performs sample size calculation

Writes Blind Review plans and reports

Writes and review statistical parts of scientific articles

Prepares and reviews Statistical Analysis Plans

Advises other staff and clients on statistical methodology and statistical principles

Participates and conducts Blind Review meeting

Supports the presentations to clients and manages the technical communications with client when assigned as lead statistician to a study

Create SAS programs for Datasets and TLFs validation

Prepares and performs training to internal / external staff on statistical methodology and statistical principles

Provides statistical input to the design and review of Protocols and Case Report Forms

Participates to DMC / DSMB meetings

Provides support to DMC / DSMB charter preparation

Reviews the specifications for analysis datasets

Conducts other activities as required

DESIRED QUALIFICATION & EXPERIENCE

At least 3 years of experience in Biostatistics

TECHNICAL COMPETENCES & SOFT SKILLS

SAS Programming, Good

Broad Range of Statistical methodology skills, Very Good

ICH E9 Statistical Principles for Clinical Trials, Very Good

MS Office Suite, Good

Professional

Trustworthy

Ability to effectively prioritize

Quality focused

Willingness to learn

Team Player

Learning Agility

Ability to Manage Conflict

Problem Solving Skills

Commercial and Technical Writing Skills

Networking Skills

Languages

Education

Bachelor of Arts (BA) : Statistics

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values : be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Senior Statistician provides statistical and methodological input necessary to plan, conduct, analyse and interpret results for studies in Phases I-IV and across studies for submission in a variety of therapeutic areas and in both medical device and drug settings.

KEY RESPONSABILITIES

Carries out tasks assigned within the timelines and the standards of quality

Provides supervisions on tasks carried out by biostatisticians

Preparation of Statistical Analysis Plans

Writing of the statistical methodology and results sections of reports

Provides statistical input to the design and review of Protocols and Case Report Forms

Prepares and performs trainings of other staff and clients on statistical methodology and statistical principles

Writes and reviews the statistical methodology and results sections of reports

Review of Statistical analysis (tables, figures and listings) and specifications of clinical trials

Performs sample size calculation

Writes Blind Review plans and reports

Writes and review statistical parts of scientific articles

Prepares and reviews Statistical Analysis Plans

Advises other staff and clients on statistical methodology and statistical principles

Participates and conducts Blind Review meeting

Supports the presentations to clients and manages the technical communications with client when assigned as lead statistician to a study

Create SAS programs for Datasets and TLFs validation

Prepares and performs training to internal / external staff on statistical methodology and statistical principles

Provides statistical input to the design and review of Protocols and Case Report Forms

Participates to DMC / DSMB meetings

Provides support to DMC / DSMB charter preparation

Reviews the specifications for analysis datasets

Conducts other activities as required

DESIRED QUALIFICATION & EXPERIENCE

At least 3 years of experience in Biostatistics

TECHNICAL COMPETENCES & SOFT SKILLS

SAS Programming, Good

Broad Range of Statistical methodology skills, Very Good

ICH E9 Statistical Principles for Clinical Trials, Very Good

MS Office Suite, Good

Professional

Trustworthy

Ability to effectively prioritize

Quality focused

Willingness to learn

Team Player

Learning Agility

Ability to Manage Conflict

Problem Solving Skills

Commercial and Technical Writing Skills

Networking Skills

Languages

Education

Bachelor of Arts (BA) : Statistics

Contract Type

Regular

Summary

• Type : Full time

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