Assistant Director - Nddd (Lrp)

A) Job description:-
1) Serve as the lead statistician on clinical development programs (biosimilars, NCEs, new products).
2) Contribute in planning, methodology, and analysis for Phase 1-3 clinical studies, not limited to protocol development, sample size calculations, reviewing/authoring of statistical analysis plans, data review, statistical reports, analysis implementation and statistical interpretation of results in the CSR.
3) Review of case report forms (CRFs), data management plans, data specifications and clinical study reports, creation/review of randomization schedules, provide statistical analysis and reports to Data Monitoring Committees (DMCs) etc.
4) Review the mock-ups of tables, listing, and figures and dry-run data to ensure alignment with planned analysis strategy.
5) Collaborate with internal team and / or CROs to assure that all programming and statistical analyses are completed as planned.
6) Provide statistical support for responding to regulatory authorities related to submissions and during review cycles for protocol, marketing authorization applications.
7) Provide oversight and inputs in statistical programming / creation, conversion, and formatting of datasets as per regulatory requirements.
8) Participate in the development and maintenance of relevant SOPs.
9) Serve as the statistical representative on cross-functional teams including but not limited to clinical operations, data management, programming, medical writing, and regulatory for all matters pertaining to statistics.
10) Review/relay the Top Line results to the appropriate parties.
11) Experience working with estimands, bayesian statistics, biosimilars and NCEs will be given preference.

B) Relevant work experience - 6 to 12 Years.

C) Education Qualification - MSc / PhD.