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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical consulting and guidance throughout the clinical development process, with a strong focus on regulatory interactions, innovative trial designs, and protocol optimization. Possesses a thorough understanding of statistical models and regulatory requirements across therapeutic areas.
Highest-signal resume keywords
PhD In StatisticsRegulatory SubmissionsInnovative Trial DesignsStatistical ModelsClient Interactions
ATS Keywords
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Hard Skills
Statistical ConsultingClinical Development ProgramsProtocol OptimizationRegulatory GuidanceStatistical ApplicationsDrug DevelopmentDevice DevelopmentDiagnostic DevelopmentProposal DevelopmentConference Presentations
Soft Skills
Communication SkillsNegotiation SkillsProblem-Solving SkillsAnalytical SkillsOrganizational Skills
Industry Keywords
ICH GuidelinesGood Clinical PracticesFDAEMEAMHRAPMDANMPATherapeutic AreasRegulatory AuthoritiesThought Leadership
About the role
Key responsibilities & impact- Provide statistical consulting and guidance throughout the clinical development process
- Provide statistical expertise in the design of clinical development programs and individual protocols
- Optimize existing protocols and prepare submissions across therapeutic areas and indications
- Interact with clients and regulatory authorities, including representing clients at key regulatory meetings
- Lead or contribute to client meetings on innovative study designs, analysis concepts, and presentation, discussion, and interpretation of study results
- Provide technical leadership and advise internal teams on advanced or innovative statistical designs, models, applications, and complex statistical issues in clinical trials
- Attract new business by serving as a Biostatistics expert and partnering with Business Development, Medical, Solutions Consultants, and other functions
- Contribute to proposal development and attend bid defense meetings
- Represent Parexel at client marketing and technical meetings and support lead generation through networking, public speaking, and thought leadership
- Coordinate client or account activities for the department or function
- Participate in committees and task force groups
- Partner with senior departmental management to develop biostatisticians
- Maintain working knowledge of and ensure compliance with ICH Guidelines, Good Clinical Practices, regulatory agency requirements, and Parexel standard operating procedures
- Participate in departmental meetings, training initiatives, and project team meetings
- Maintain effective relationships with departments, clients, and regulatory agencies
Requirements
What you’ll need- PhD in Statistics or a related discipline, or MS in Statistics or a related discipline
- Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge
- Direct consulting experience
- Experience designing and executing drug, device, or diagnostic development programs
- Demonstrated successful direct interactions with relevant regulatory agencies such as FDA, EMEA, MHRA, PMDA, NMPA, or other local agencies
- Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation
- Thorough understanding of regulatory guidance and practices related to specific indications and the submission and approval process
- Experience with conference presentations and manuscript writing
- Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills
- Technical leadership and ability to contribute to a high-performing team
- Expertise in innovative trial designs, protocol and development program optimization, submission strategies, and regulatory interactions
- Strong understanding of drug, device, or diagnostic development across different therapeutic areas and indications
- Thorough understanding of statistical models, applications, and statistical issues in clinical trials
- Ability to collaborate across functions and communicate complex statistical concepts credibly to clients, internal teams, and regulatory authorities
- Preferred: expertise across multiple therapeutic areas and indications
- Preferred: experience advising on advanced or innovative statistical designs, models, and applications
- Preferred: experience supporting proposals, bid defense meetings, client presentations, public speaking, or thought leadership
Benefits
Comp & perks- Occasional travel, mostly within Europe
- Applicable bonus plans or incentive structures for eligible positions