- Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
- Perform protocol development, sample size calculation and justification, protocol and CRF review.
- Advise data management staff on database design, and critical data. May advise on validation checks.
- Write and review statistical sections of integrated reports.
- Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
- Act as statistical team lead for single complex studies or groups of studies.
- Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
- Provide support in preparation of RFPs and QIPs.
- Provide training and guidance to lower level and new staff.
- Any other responsibilities as assigned by the management in liaison with the organization need
- Masters Degree in Statistics/ Applied Statistics/ Biostatistics
- 5 7 years of relevant experience
- Excellent written and oral communication skills including grammatical/technical writing skills
- Excellent attention and accuracy with details
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
- Familiarity with moderately complex statistical methods that apply to applicable clinical trials
- Strong individual initiative and organizing skills
- Thorough understanding of SAP and mock shell creation & review
- Good knowledge on creation and review of Safety and Efficacy data analysis
- Good understanding of designing or providing input to the Protocol
- Strong working knowledge of SAS computing package
- Familiarity with other relevant statistical computing packages such as nQuery
- Strong commitment to quality
- Ability to effectively manage multiple tasks and projects
- Ability to lead and co-ordinate small teams
- Ability to solve moderately complex problems
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Working knowledge of relevant Data Standards (such as CDISC/ADaM)
Role:Healthcare & Life Sciences - Other
Salary: Not Disclosed by Recruiter
Functional Area:Healthcare & Life Sciences
Role Category:Healthcare & Life Sciences - Other
Employment Type:Full Time, Permanent
PG:MS/M.Sc(Science) in Statistics
Doctorate:MPHIL in Statistics
PHOENIX IT CONSULTANTS PRIVATE LIMITED
PHOENIX IT CONSULTANTS PVT LTD., : A 12 years old company & is one of the fastest growing IT Services, provides architecture and technology consulting for Application Development and Maintenance, through expert design and advisory services. These services renew existing application landscapes, in addition to delivering new applications based on next-generation architecture, Consulting, Recruitment and Outsourcing Company from India with offices currently in Bangalore (HQ) and New Delhi. We facilitate our clients to be the best in their respective fields by utilizing state-of-the-art technology, Services and solutions. While suggesting or implementing any new concept for a particular business, we Foresee all the impacts of that concept on that specific business. With technologies evolving at break-neck speed and competition getting fierce, theres a greater need than ever to consult with a technology advisor. We’ve built a world-class team of technology consultants that work with you to facilitate your digital journey. With a strong heritage of innovation and entrepreneurship in Application Services, we help companies leverage the potential from digital technologies like service now, SAP, AWS, Salesforce, Machine learning, AI, automation and Cloud. We understand, our clients’ business needs come first, our global team of technology consultants work flexibly to deliver results, be it advisory or end-to-end execution. We provide cost-effective solutions to our clients to maximize their returns. Our versatile business model and unique delivery methodologies help us achieve better results. We ensure that our clients get quality and timely solutions by keeping abreast with the latest trends in the industry.