Biostatisticians

4 days ago

Bengaluru, India Avance Clinical Full time

Reputable CRO
- Great culture and office space

**AVANCE CLINICAL**
Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.

**Broad Purpose**
As a senior member of the Biometrics-Stats team, the Senior Biostatistician is responsible for preparing, analysing and interpreting statistical data to ensure accurate reporting of results from clinical study data. The role assists with the experimental planning and design of clinical trials.

**Core Responsibilities**
- Provide statistical advice on study design.
- Provide statistical input in the development of study protocols.
- Prepare/review statistical plans and randomization schedules.
- Prepare/review listings, tables and figures for clinical study reports.
- Perform/review statistical analyses.
- Perform internal review of statistical methodology and results sections of clinical study reports.
- Liaise with Data Management team about data transfer, and the review of Case Report Forms and Data Management Plans.
- Assist with pharmacokinetic analyses.
- Liaise with bioanalytical laboratories about data transfer.
- Assist with preparation and review of clinical study reports.

**Departmental Responsibilities**
- Maintain effective communication with other members of the statistical analysis team, and study team members of other, but related disciplines.

**Qualifications, Skills and Experience**
- Ordinary degree in the appropriate discipline or appropriate industry experience.
- Higher degree in relevant discipline to Biostatistics _(highly desirable)._
- Minimum 5 years experience in statistical analysis in pharmaceutical / health research.
- Minimum of 3 years statistical programming experience.
- Working knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.
- SAS programming experience _(highly desirable)._
- Ability to communicate at a high level with clients, management and other stakeholders.
- Excellent oral and written communications skills including the ability to prepare reports and procedural documents.
- Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
- Proven ability to deliver tasks on time and with a high degree of accuracy.
- Ability to work under pressure in a multi-disciplinary team environment.

**Other**
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands as above.
- Likewise, qualifications listed are representative of the knowledge, skills and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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