Principal Biostatistician, Fsp

hace 1 semana

Ciudad de México IQVIA A tiempo completo

**Job Level**:FSP Principal Biostatistician

**Location**:Home-based in Mexico

**Why DSSS?**

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while collaborating directly with expert cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

**Job Summary**

**Responsibilities & Duties**
- Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in supporting publication projects and regulatory query responses.
- Develop statistical analysis plan, mock-up tables, quality check plan.
- Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by programmers.
- Conduct peer review of project related work performed by other statisticians, maintain compliance with the latest regulatory requirements, maintain project documentation and files according to departmental policy.
- Communicate competently and independently with client to coordinate the statistical and programming considerations of the project.
- Demonstrate strong understanding of ICH guidelines and clinical trial design, as applicable to statistics.

**Basic Qualifications**
- Masters in Statistics/Biostatistics (or related field) with 7+ years’ experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 5+ years’ experience in clinical trials.
- Effective verbal and written communication skills
- Able to fully understand clinical questions and concepts and to translate and simplify them into SAP development followed by data generation all the way through publication.
- Effective at clearly explaining statistical concepts to colleagues without statistical training
- Work collaboratively as a team member
- Experience with statistical modelling of clinical data and statistical inference
- Experience in R or SAS programming languages
- Based in a time zone within the United States or Europe (UTC-8 to UTC+1) to facilitate real-time collaboration

**Preferred qualifications**
- Strong computational skills
- Experience with different study designs, protocol development, and statistical analysis plan writing

**Note**:

- **-We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies.**

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