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New Jersey, NJ Full Time Posted by: ZS Associates Posted: Thursday, 10 June 2021

ZS' R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success. Through our Lifecycle Evidence Strategy, Clinical Trial Optimization, Medical Affairs and Real World Evidence services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS R&D Excellence Practice Area supporting our business consulting and analytics services across multiple clients

Associate Principal - Biostatistics Lead


Provide expert, strategic consultancy to RDE clients and internal teams in the areas of biostatistics, trial design, analysis, and interpretation, statistical methods and best practice, decision making, evidence generation, real world evidence, regulatory and payer submissions, and health authority interactions;
Lead development of biostatistical consultancy offerings and capabilities, collaborating through ZS service lines, account teams, and her/his professional network to engage current and prospective clients;
Lead or contribute to ZS project plans for consulting engagements and solutions requiring biostatistics expertise, ensuring delivery of projects to plan, effective translation of business requirements, and proactive identification, mitigation, and management of relevant risks and issues, as appropriate;
Maintain broad knowledge and awareness of relevant regulatory and technical trends, requirements, and guidance, as well as applicable ZS capabilities and operating models, and industry or technology trends;
Develop and maintain effective collaborations/relationships with industry and client-company opinion leaders, external regulatory, industry, professional, and academic organizations, and within RDE/ZS;
Accountable for her/his team or individual contributions (as appropriate) to meet or exceed the relevant quality, compliance, and documentation requirements in all respects, as per ZS standard processes, client contracts/agreements, and Good Clinical/Laboratory Practice (GCP/GLP/GxP);
Anticipate and take prompt action on new/expanded ZS resources/capabilities needed to drive current and future RDE success, including leading or contributing to business cases, plans, and actions;
Provide direction, best practice, and facilitation to ZS Operations, Technology, and Consulting teams supporting RDE, and to client project teams where appropriate;
Lead or contribute to timely development of creative, clear, and impactful (winning) responses to client queries, requests, and solicitations;
Lead, deliver, or contribute to engaging, impactful presentations and workshops for stakeholders and current/prospective clients and partners, or by representing ZS at industry conferences and events;
Achieve substantial impact with clients and partners, and within ZS, through her/his strategic leadership and expert influencing, communication, stakeholder management, and change management skills;
Actively and impactfully use expertise and knowledge to lead/contribute to ZS innovation, improvement, and business development initiatives, including client/internal business case and requirements development, needs assessments, and solutioning options for RDE and other ZS service lines;
Coach and mentor individuals and teams, and contribute to capability building, knowledge sharing, best practice, lessons learned, and general leadership across ZS, as appropriate;
Strive at all times to realize the highest standards for the impact and image of ZS and ZS leadership.

MSc (PhD preferred) in Statistics or Mathematics with a substantial statistics component;
Extensive experience in pharmaceutical development, program/trial design, data analysis and interpretation, global health authority and payer submissions, and health authority interactions;
Substantial industry reputation and profile based on statistical and/or drug development expertise (eg, publications in high-quality scientific journals);
Extensive knowledge of current and emerging statistical and relevant regulatory expectations;
Extensive knowledge of global health authority submission requirements for new/supplemental drug or medical device applications;
Demonstrated ability to apply statistical expertise and problem solving to complex scientific, quality, and business challenges using variety of data sources, eg historical trial data, real world data
Demonstrated expertise in clinical data standards (eg, CDASH, SDTM, ADaM, HL7);
Experience with database, statistical, and/or application programming in pharmaceuticals/healthcare and/or clinical drug/medical device development (eg, SAS, SQL, R, Python);
8-10 years of relevant consulting industry experience working on client delivery engagements;
10+ years of experience in drug/medical device development;
Proven ability to lead and influence clients and project teams in area of expertise;
Thorough understanding of client relationship management, pre-sales activities, and conflict resolution;
Proficient in managing a large and complex portfolio of projects and activities;
Awareness of current clinical data technologies and trends within pharmaceutical R&D;
Ability to distill complex concepts into easy-to-understand frameworks and presentations;
Proficient to Expert skills in collaboration, communication, problem solving, project/risk management, and stakeholder management;
Proven relationship-building and maintaining skills with clients and across functional areas;
Superb verbal and written communication, organization, analytic, planning and leadership skills;
Able to motivate and empower diverse, global teams in a Matrix organization;
Willingness to travel to other global offices as needed to work with client or other internal project teams.

New Jersey, NJ, United States of America
ZS Associates
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6/10/2021 3:39:36 AM

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