Biostatistician

6 days ago

Vikhroli Mumbai Maharashtra, India Cipla Full time

**Division**:
IPD

**Department**:
Clinical R&D

**Employment Type**:
Permanent

**Job Purpose**:
Plan, execute and control the statistical analysis plans for clinical trials, preclinical studies as per the clinical strategy to generate robust and quality data within allotted budget and timelines to facilitate successful product registration. Also ensure safety and efficacy summaries in compliance with ICH-GCP.

**Accountabilities**:
I. Develop and implement design Sample size calculation

II. Review protocol Deviations and Provide statistical inputs in the protocol design to

III. Design, implement and monitor statistical aspects of clinical and preclinical studies and provide summary across studies.

IV. Development and monitoring implementation of Statistical Programming and Standardized Datasets

V. Driving simulation analysis through pharmacokinetic /pharmacodynamic modelling.

VI. Supporting the clinical science team in performing supplementary analysis for setting up robust statistical model for the clinical study

VII. Drive effective project communication to ensure sound decision on Statistically requirement by doing cross functional project team meeting and sharing consistent information across stakeholders on progress

VIII. Provide oversight on statistical aspects to Preclinical/Clinical/BABE and cross function team

**Education Qualification**:

- M.Sc. Statistics
- PhD, Statistics
- Working knowledge of Statistical softwares; Understanding of data management principles for clinical trials and medical research; Working knowledge of regulatory requirements for clinical trials and medical research; Applied knowledge of advanced statistical models

**Relevant Work Experience**:

- 5- 15 years’ experience in clinical research domain

**Competencies/Skills**:

- Communication Skills (clarity of thought, comprehension)- Likely potential for growth- Job / Product / Technical Knowledge / Pharma domain knowledge- Presentation & Interpersonal skills (If applicable)- Managerial or People Management skills- Safety awareness (If applicable)- Relevance of Previous Experience- Comprehension, Analytical & Problem solving abilities- Productivity & Result Orientation (If applicable)- Attitude- Qualification fitment- Sales drive (If applicable)- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)**Job Location**:
**Shift Hours**:

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