Opening for Senior BioStatistician | Hyderabad

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Senior BioStatistician | Hyderabad

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.
Assists with interviewing and training new hires as needed.
Reports to Director of Biostatistics and Data Management.
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.
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. Three to Five 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 required. 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.

City

Hyderabad

Country

India [IN]