Summary

-Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines.

• Responsible for all statistical tasks on the assigned clinical trials and perform these tasks for mid- to high complexity trials independently with peer review/input as required. Responsible for protocol development in alignment with the clinical development plan, developing statistical analysis plan, study and indication-level reporting activities.

• Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician.

• Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, significantly contributing to meetings with and responses to Health Authorities and other drug development activities, as required.

• Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.

• Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the trials.

• Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.

• Establish and maintain collaborative relationships and effective communications cross- functionally within the Clinical Trial Team and Biostatistics & Pharmacometrics team.

• Ensure all Biostatistics deliverables for assigned clinical trials and/or non-clinical related activities are delivered in a timely manner with the highest level of quality.

• Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors.

• MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years' relevant work experience.

• Fluent in English with strong communication and presentation skills.

• Influences decisions that directly impact the trial/project and team ability to deliver objectives.
• Demonstrable experience in all tasks of a statistician at trial and experiment level with the ability to work independently.Demonstrable knowledge and expertise in statistics and its application to clinical trials; ability to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills.

• Proficiency in use of statistical software packages (e.g. SAS, R).
• Good knowledge of drug development and Health Authority guidelines.
• Demonstrated efficiency working on a multidisciplinary team to achieve team objectives.

• Understanding of Franchise/Therapeutic Area and/r regulatory activities.

• Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions.