Biostatistician II
India, Remote Additional Locations: Bengaluru, Karnataka, India; Chandigarh, Punjab, India; Hyderabad, Telangana, India; Mumbai, Maharashtra, India; SAS Nagar (Mohali), Punjab, India; Job ID R0000024207 Category Biostatistics Date Posted 07/03/2024Overview
As a member of Parexel’s Biostatistics group, your expertise in statistical methodology, and data analysis plays a crucial role in providing evidence to support the safety and efficacy of new health treatments. You contribute to research design and analytical strategies, provide input into protocols, and develop and review statistical analysis plans, all while working with the patient in mind.
Parexel's Biostatisticians work in global cross-functional teams where idea-sharing is encouraged, and you constantly learn. Our flexible, supportive, and inclusive working environment provides the space to work at your best wherever you are, voice your opinions, and contribute to the success of the team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Analytical
- Collaborative
- Detail-oriented
- Efficient
- Problem-solver
- Quality-focused
About This Role
Position Summary:
The Biostatistician II is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS (Global Biometric & Data Sciences) Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians II's are individual contributors and report to a GBDS Lead.
The Biostatistician II is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician II has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data.
Key Responsibilities:
Independently leads the development and execution of statistical aspects for studies of low to moderate complexity.
Participates in PRC reviews of study protocols and SAPs.
Provide data interpretation for study documents, e.g. CSR.
Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product.
Develops trial designs that address study objectives that will support regulatory approval and market access.
Translates scientific questions into statistical terms and statistical concepts into layman terms.
Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information.
Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
Communicates effectively with clinical and regulatory partners and external opinion leaders.
Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents.
Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted.
Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables.
Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information.
Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles.
Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
Drives alignment at study team level and escalates lack of team alignment to the GBDS Lead for resolution.
Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
Keeps up-to-date with state-of-the art applied statistical methodology.
Understanding of CDISC standards and implementation guides.
Skills, Knowledge, and Experience:
Minimum Requirements:
Master's degree in Statistics or equivalent & ≥ 3 years of industry related experience.
Or
Ph.D. in Statistics or equivalent & ≥ 1 years of industry related experience.
Preferred Requirements: Must Have
Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals.
Excellent verbal and written communications skills.
Ability to be flexible and adapt quickly to the changing needs of the organization.
Ability to organize multiple work assignments and establish priorities.
Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
Project Statistician Specifics
Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.
Relevant prior data analysis planning, execution and delivery experience.
#LI-REMOTE
Potential Career Path
Parexel offers career paths for Biostatisticians to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Biostatistician I
- Biostatistician II
- Senior Biostatistician
- Principal Biostatistician
- Subject Matter Leadership PathwayPeople Management Leadership Pathway
Employee Insights
Why Biostatisticians work at Parexel
