Requirements: English
Company: Akkodis
Region: italia, italy ,
Biostatistician
Our mission at Akkodis is clear: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.
With our 360° offer we support companies in all sectors in implementing Smart Industry solutions, from the up- and reskilling of entire teams to the delivery of complete projects.
Our added value? Make the incredible happen!
At Akkodis, you can take your career into the direction you want: choose a consulting role, become part of a solutions teams or be at the forefront of new innovations from within our own research centres the choice is yours!
JOB DESCRIPTION :
As a biostatistician, you provide expert statistical input and contribute to development plans, design, protocol writing, statistical analysis, and interpretation of results from clinical studies. You are accountable for timely availability of high-quality analysis results to support decision making. You provide statistical oversight and guidance to teams and outsourcing partners.
Tasks and responsibilities in each field:
- Provide statistical input to the design, analysis, and interpretation of results from clinical studies, and development plans in close interaction with different stakeholders (e.g., clinical representatives, safety team, data management team)
- Write and review key clinical and statistical documents (e.g., Protocol, Statistical Analysis Plan [SAP], Data Management Plan [DMP], Prescription Drug Monitoring Program [PDMP], Case Report Form [CRF], Clinical Study Report [CSR])
- Provide high-quality and timely statistical analyses results to support correct and timely decision making.
- Act as a statistical representative within cross-functional study teams and project sub-teams and provide statistical support and solutions.
- Provide statistical support for briefing books, submissions, health authorities requests, publications, and other relevant documents.
- Support interactions with health authorities
- Provide input to internal process improvements and/or new statistic capabilities.
- Maintain current scientific and regulatory knowledge.
Competencies required for support level:
- Msc. or PhD in Statistics or related field
- Experience as a statistician in the pharmaceutical industry
- Proficient in English (oral and written)
- Good programming skills in SAS (Macro, SQL) and R (function, package)
- Strong statistical methodology knowledge applied to non-clinical/pre-clinical/clinical projects.
- Able to propose and implement new statistical methodologies.
- Excellent knowledge of GCP and ICH guidelines
- Excellent communication skills, able to build good relationships with internal and external stakeholders, able to explain advanced statistical concepts in terms understandable to non-statisticians.
- Leadership, able to lead a statistical and a programming team.
- Able to manage, drive and meet delivery timelines.
- Team player, able to work in multidisciplinary teams.
- Excellent knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10)
- Technical knowledge of CDISC standards (ADaM, SDTM)
- Strong experience in submission and interaction with health authorities