eteraflex connects
Website:
eteraflexconnects.com
Job details:
eteraflex connects is a specialized contract research organization (CRO) delivering top-tier clinical trial services to pharmaceutical, biologic, biotechnology, and medical device/diagnostic companies. eteraflex provides a technology-enabled service offering that combines deep clinical services expertise with the technology clients need to be successful in their clinical trials, supporting programs from compound selection through Phase I-IV studies.
Position Summary:
As a Principal Biostatistician, you will serve in a senior technical role within the global Biostatistics team, delivering and project managing assigned studies across Phases I-IV in a variety of therapeutic areas. This is a hands-on technical position; you will act as the lead statistician on clinical studies of moderate to high complexity and/or high value and impact for the organization. You will apply a high level of technical expertise, provide senior-level peer review of work accomplished by other biostatisticians, and maintain the statistical and analytical integrity of clinical trials analyzed by eteraflex connects. You will personally own planning, execution, and delivery of biostatistics and programming activities on your assigned studies, ensuring studies and integrated analyses are delivered on time, on budget and to required quality, while also supporting business development and project management with strategic planning, proposals, pricing, and timeline planning.
Primary Responsibilities:
· Serve as an internal consultant and subject matter expert for biostatistics analysis tools and methods during client, vendor, and multifunctional meetings.
· Contribute statistical input to clinical development plans (CDP), including study design, sample size, primary/secondary endpoints, and statistical analysis methods.
· Provide statistical expertise for study design of clinical trial protocols; check protocol outlines and write the statistical methods section of the study protocol as needed.
· Prepare and review Statistical Analysis Plans (SAP) and specifications, ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
· Provide statistical input to the design and review of Case Report Forms (CRFs) to ensure consistency with protocol and SAP.
· Perform sample size calculations and produce randomization codes/schemes.
· Act as the lead statistician on clinical research projects and hands-on contributor for SAS programming.
· Provide specifications to SAS programmers for generating analysis datasets.
· Program and develop final summary tables, data listings and figures for final study reports (FSR), publications, and regulatory submissions.
· Perform all analyses defined in the SAP as well as any post-hoc and relevant exploratory analyses of clinical trial data; interpret and report results.
· Review statistical analysis outputs (tables, figures and listings), including validation support if required.
· Prepare and review key sections of clinical study reports, integrated study reports, and various regulatory documents including statistical methodology and results sections.
· Perform statistical QC of all department outputs including analyses and clinical study reports.
· Review and approve database structure, edit-check specifications, and data management coding conventions.
· Evaluate other clinical documents such as clinical operation manual, investigator brochure, etc.
· Support responses to regulatory questions on program design and any labelling claims following submission; provide statistical support to answer questions from external clients (such as FDA, investigators).
· Represent the biostatistics department at regulatory meetings, sponsor meetings, investigator meetings, and any other multifunctional meetings as needed.
· Actively support business development with capabilities presentations and contribute to eteraflex research proposals and marketing meetings with prospective and current clients.
· Effectively manage assigned clinical study budgets, biostatistics timelines, and client expectations for biostatistics analysis support.
· Prepare and deliver training for staff and clients on statistical methodology and principles.
· Provide informal technical guidance and peer review to fellow biostatisticians in a senior technical capacity (no direct reports).
· Contribute to the development, maintenance, and training of standard operating procedures (SOPs).
· Drive incident management, process improvement, and process modeling initiatives within the Biostatistics function.
· Adhere to all aspects of Eteraflex Connects' quality system and comply with data integrity and business ethics requirements.
· Adhere to all essential systems and processes required at eteraflex to maintain compliance with business and regulatory requirements.
· Perform other related duties incidental to the work described herein.
Skills and Experience Required:
· Master's degree in Statistics, Biostatistics or related field (Ph.D. preferred) with substantial clinical trials experience; CRO experience strongly preferred.
· Demonstrated experience in methodological biostatistics across Phases I-IV.
· Previous experience leading studies in a senior technical capacity, including leading a regulatory submission.
· In-depth knowledge of study designs and statistical analysis applications in one or more therapeutic areas (oncology experience a plus).
· Strong hands-on SAS programming skills and excellent knowledge of statistical software packages.
· Excellent knowledge of clinical trials methodology and regulatory requirements.
· Excellent verbal and written communication, interpersonal and project management skills.
· Ability to translate clients' needs into statistical practice and educate clients in the use of statistics.
Primary Skills:
· Incident Management
· Process Improvement
· Process Improvements
· Process Modeling
Location: Bangalore, Delhi and Hyderabad - Fulltime
Work Schedule: UK Business Hours
(Afternoon-Evening IST)
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