(In Yrs.) Minimum 9 years of relevant experience in performing biostatistics and programming tasks for clinical trials
Must Have Technical/Functional Skills • Proficient in programming languages such as SAS and R. • Proficient in using statistical softwares like SPSS, Minitab for data analysis.
Roles & Responsibilities
1. Develop protocol in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses. Initiate, drive, and implement novel methods and innovative trial designs in alignment with the Project Statistician.
2. Lead statistical/numerical/analytic research by providing advice and solutions on computational aspects of the problem.
3. Guide the trial statistician to ensure that documents, specifications, are consistent and comply with company standards by providing input into CRF and data structures tables, listings, and figures studies.
4. Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, and scientific analytical solutions.
5. Oversees statisticians and deliverables for assigned trials and at a therapeutic area level. If required, lead study teams to ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
6. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support all activities and documents.
7. Maintain efficient interfaces with Sr or Jr Statistician, internal and external customers as needed.
8. Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
9. Develop and comply with project / study standards and specifications following internal guidelines.
10. Support quality control and quality audit of deliverables.
11. Provide input on process improvement initiatives and participate in non-clinical project activities Project Lead.
12. Participate in non-clinical project activities as needed. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings.
13. Provide support, coaching and mentoring to new hires, senior and junior statisticians.
14. Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with oversight as appropriate.
15. In cooperation with the Trial Programmer, write statistical programming procedures/specifications and define the QC validation plan.
16. Ensure statistical integrity of the study report following internal standards and regulatory guidelines in compliance with SOPs.
17. Participate and provide input in meetings (e.g., Operational Meeting, organized by Clinical operation Lead; investigators meeting.
18. Support statistical programmer for TSAP implementation and statistical QC of programs, Finalization of QC/Validation.
19. Support in preparation of Clinical Trial Report (CTR).
20. Support electronic submission.
21. Present basic concepts of statistics to non-statisticians at work and to do high level presentations on topics of biostatistics like (Estimands, adaptive designs, longitudinal data models etc.,) as per requirements.
Generic Managerial Skills • Should be able to communicate clearly and concisely with stakeholders, and customers this includes active listening, display empathy. • Should be able to set goals and expectations and be a positive role model for the team. • Should take complete ownership as the trial statistician involved in communication and coordination with the clinical stakeholders. • Coaching and mentoring for the team.
Education
Postgraduate or PhD in Statistics or Applied Statistics