BioStatistician | Gurgaon
Position Overview Provide scientific statistical support & advice.
Represents Biostatistics and Data Management (BDM) on project teams, coordinates BDM project related activities and develops plans and timelines for the statistical activity on delegated projects. with interviewing and training new hires as needed.
Reports to Group Leader.
Works across international and functional boundaries as needed within a project team environment.
Works closely with Clinical, Medical, Statistics and Data Management team members.
Responsibilities
Provide scientific statistical input to development plans and to project planning as needed.
• Provide study design recommendations and prepare sample size calculations for Outline Protocols.
• Prepare statistical section for Clinical Study Protocols.
• Generate randomisation schedules for clinical trials in accordance with protocols and maintaining security of schedules before and during the studies.
• Review Clinical Protocols.
• Provide input to the design of Case Report Forms and review discrepancy/edit check specifications.
• Approve Case Report Forms
• Prepare Statistical Analysis Plans.
• Interact with Statistical programmers regarding programming requirements for analysis and reporting.
• Perform and Validate/QC statistical analysis.
• Prepare the statistical section of Topline and Final Clinical Study Reports.
• Review Final Study Reports.
• Present and discuss results with internal/external bodies as required.
• Hold project team meetings as needed.
• Generate and maintain study documentation
• Attend and participate in project team meetings
Requirements MSc in (Bio) Statistics from a recognized institution (like e.g. Indian Statistical Institute), MPhil a plus.
Two years experience as a statistician (not as a programmer) in pharmaceutical industry or a clinical research organization with responsibilities in clinical trial analysis and reporting. SAS programming skills. Knowledge and experience in pharmacokinetic studies desired. WinNONLIN experience highly desirable. Experience with the following methodologies desirable: General Linear models - ANOVA, ANCOVA, t-test, F-test, etc (mixed models a plus); Non Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression. Familiarity with relevant GCP/ICH/FDA regulations. Excellent verbal and written communication skills in English. Ability to work on multiple projects, plan, organize and prioritize activities.
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