Bangalore – Whitfield
Note : We are looking for someone who is form Biostatistics background, candidates must have strong experience into Biostatistics.
Overview:
The Associate Director, Biostatistics provides input regarding planning, management and logistics for biostatistics and statistical programming services. The AD, Biostatistics will assist in developing the strategic vision for all biostatistics activities. The AD, Biostatistics will work closely with clients and provide high level consulting services for statistical analysis, reporting and statistical programming specific activities which may include development of statistics section of the protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming, and reporting output, and developing statistical analysis report. The AD, Biostatistics will also work on statistical programming for development of analysis datasets, clinical tables, listings and graphs specific to the trial reporting requirements.
The AD, Biostatistics and Statistical Programming will work as needed assuring that all client work has met or exceeded expectations.
The position reports to the Director, Biometric Services, India
Key Tasks and Responsibilities:
· Provide input regarding planning, management and logistics for biostatistics and statistical programming services.
· Asist in developing the strategic vision of the department which can be integrated into the overall corporate vision.
· Support the development of policies, procedures, and standards.
· Participate in resource management and allocation activities.
· Provide consulting of statistical activities related to clinical trials. Fulfil the responsibilities of study statistician as required.
· Provide mentoring and QC of statistical programmer’s output; define analysis data specifications. If required, validate the statistical model used for programming.
· Act as study/trial statistician; interact with client and with clinical team including programmers, clinical data managers, clinical protocol managers and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time.
· Develop, review and finalize the statistical analysis plan (SAP).
· Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis.
· Develop randomization schedule, specifications and guidelines.
· Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting.
· Wherever applicable, develop, validate and finalize the study specific list of tables, shells for clinical study reports and for study specific deliverables.
· Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately.
Candidates Profile:
Education & Experience
· A minimum of MSc in Statistics
· 8-10 years of clinical industry experience
Professional Skills
· Should have led studies as lead/trial statistician with proven track record of leading and managing highly motivated statisticians.
· Ability to work with cross functional teams, coordinate with stakeholders (internal and external), represent the Biostats and SP teams in the client CTT.
· Proven track record of providing guidance and mentoring to team members.
