Biostatistical Specialist Firenze

Biostatistical Specialist
Firenze
Toscana, Firenze

Contract type**: permanent

Workplace: Florence / full remote

For the leading italian pharmaceutical company in the world we are looking for:

**BIOSTATISTICAL SPECIALIST

**CONTEXT

The Biostatistical Specialist will join the Clinical Science department of Company's Research, the R&D organization of the Group in Florence.

He/She will reports to Biostatistics Manager for the oncology area, being responsible for all statistical tasks on the assigned clinical trials, and performing these tasks with a total independence

**MAIN ACTIVITIES AND RESPONSIBILITIES

- Study planning and design, including the statistical part of the protocol and the final report

- Statistical analysis plan (SAP) development

- Sample calculation also with simulations

- Planning and / review of the analysis from SAP and any exploratory analyses

- Supervision of the activities assigned to junior staff (or management of small work teams)

- Supervision and management of statistical and data management activities assigned to CRO

- provide precise indications for the design of the eCRF, IRT, ePRO and review the related technical

specifications

- Collaboration in the preparation of documents for scientific advice to regulatory bodies

- Collaboration in the drafting of scientific articles

**JOB REQUIREMENTS

- Experience: minimum 3 years in the role of bio-statistician in clinical research (company or CRO) is required, with particular reference to phase I-III registration studies in oncology area

- Biostatistics master's degree is preferred

- Fluency in English

- Technical knowledge - must have:

Advanced SAS programming

Detailed knowledge of CDISC standards (i. e.

: SDTM, ADAM)

Knowledge of the main guidelines (EMA / FDA)

- Technical knowledge - nice to have:

eCRF design

Knowledge of other statistical programming package

**Workplace: Florence or /smart/ full remote