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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Biostatistics and statistical methodologies within clinical development, with a strong focus on regulatory submissions and cross-functional collaboration. Proven ability to lead teams, manage resources, and drive process improvements while fostering an inclusive and high-performance culture.
Highest-signal resume keywords
PhD Or MS In StatisticsClinical Trials ExperienceProficiency In SAS, R, Or PythonAdvanced Statistical AnalysisDirect Or Matrix Management Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
BiostatisticsStatistical AnalysisData ManipulationGraphingSimulationStatistical MethodologyRegulatory SubmissionClinical Development PlansResource ManagementBudget Management
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsLeadership SkillsMentoring
Industry Keywords
Pharmaceutical IndustryHealthcare ExperienceGlobal Regulatory AgenciesSOPsStakeholder Collaboration
Tech Stack
Tools & technologiesPython
About the role
Key responsibilities & impact- Lead the Biostatistics function within therapeutic areas
- Provide statistical input to development strategies and implementation plans supporting product development or market access objectives
- Collaborate with cross-functional groups to establish study designs, analyses, and strategies
- Establish best practices for planning, execution, interpretation, and regulatory submission of clinical projects and studies
- Guide and manage statisticians to ensure high-quality and timely deliverables
- Manage resources, set priorities, and ensure consistency and adherence to standards
- Manage functional or project budgets and allocate company resources across multiple compounds or indications
- Contribute to Clinical Development Plans, submissions, and post-submission strategies, preparation, and defense
- Represent the company in interactions with global regulatory agencies
- Drive process improvement, contribute to departmental SOPs, and provide training
- Participate in industry-wide technical discussions and represent the company in professional societies
- Anticipate issues and oversee their resolution
- Serve as a scientific and strategic partner on high-level development teams
- Establish and maintain cross-functional stakeholder collaborations
- Set functional goals and support forward planning
- Communicate the DQS Mission and Vision
- Foster inclusiveness, respect for diversity, compliance, and constructive challenge
- Coach, mentor, empower, and develop team members
- Guide employee development plans, conduct performance reviews, provide feedback, and develop staff performance metrics
Requirements
What you’ll need- PhD or MS (12+ years’ experience) in statistics, biostatistics, or a related scientific field
- Clinical trials, drug development, pharmaceutical industry, or healthcare experience
- Proficiency in scientific computing/programming using SAS, R, or Python
- Advanced statistical analysis, data manipulation, graphing, and simulation
- Expertise applying statistical and clinical trials methodology to complex statistical problems in clinical development
- Experience aligning work with regulatory agencies and industry standards
- Extensive experience preparing for and participating in global regulatory agency interactions
- Excellent interpersonal, communication, writing, organizational, and leadership skills
- Experience developing resourcing strategies and recruiting practices
- Experience working with senior leaders to define positions and organizational structure
- Ability to anticipate future requirements and specialty areas
- At least 5 years of direct or matrix management experience is preferred for people manager positions
Benefits
Comp & perks- Additional discretionary incentive cash and stock opportunities
- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) for U.S.-based exempt employees
- 11 paid company holidays each year
- 160 hours of paid vacation annually for eligible new hires
- 3 optional holidays for eligible employees
- Paid sick leave
- Up to two paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- Annual Global Shutdown between Christmas Day and New Year's Day