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Principal Statistician | Senior Principal Biostatistician (W2 Only)

MDA Edge

Role overview

Qualifications

  • Ph.D. in Statistics or Biostatistics with 4+ years of experience, or MS with 6+ years in the pharmaceutical or CRO industry
  • Proficiency in SAS programming and statistical software
  • Strong knowledge of industry standards including ICH guidelines, CDISC data structures, and FDA statistical requirements
  • Proven experience in reviewing CRF designs, database specs, edit checks, and clinical documents

Responsibilities

  • Review clinical trial protocols and contribute to the design of study elements, including sample size calculations, statistical methodology, and timelines
  • Author and/or review statistical sections of protocols, SAPs, TFL shells, and variable derivation specifications
  • Monitor study conduct, quality surveillance plans, and data quality throughout the trial
  • Collaborate effectively with cross-functional teams, CRO statisticians, statistical programmers, and vendors

Key facts

Hard skills

Statistical Analysis Clinical Study Design SAS (Software) Biostatistics Data Integrity Statistical Reporting

Other skills

  • Communication
  • Organizational Skills
  • Problem Solving
  • Team Leadership
  • Adaptability
  • Detail Oriented
  • Mentorship
  • Collaboration

About the company

MDA Edge logo

MDA Edge

Business Consulting & Services

Our objective is to establish an exceptional ecosystem by connecting individuals, technology, and prospects through the application of human intelligence.MDA Edge is a process-oriented company and our expertise lies in providing comprehensive Workforce Solutions, specifically focusing on Contingent Staffing, Bulk/Project Staffing, RPO/KPO/BPO, and Direct Hire services. We cater to a wide range of industries, including Infrastructure Consulting, Engineering Consulting, IT Consulting, Healthcare, Life Sciences, Pharmaceutical Consulting, Consumer Goods, Education, Transportation & Logistics, Media & Entertainment, Telecom, BFSI, Manufacturing, Utilities & Energies, and Corporate Recruitment. Moreover, we have developed a dedicated focus on Government Consulting.Our company prides itself on a meticulous approach, ensuring that we meet your specific needs. We have established a robust network of highly skilled professionals who are readily available to fulfill your requirements. With a strong commitment to excellence, we consistently deliver exceptional results for clients in India, Denmark, France, Germany, Ireland, Japan, Spain, Thailand, the USA, Canada and Mexico, with ongoing expansion efforts to serve more new regions in the near future.We consistently uphold the highest standards of quality by providing resources, time, and materials to design, implement, and support efficient operations for organizations. Our track record of measurable accomplishments demonstrates our commitment to cultivating a balanced work and societal ecosystem.Our continuous growth, successful customer engagements, and strong customer retention exemplify our achievements. Furthermore, our passion lies in streamlining complex business processes through the application of suitable technology, which has been integral to our success.We extend an invitation to join our dynamic workplace, offering rapid growth opportunities, excellent employee benefits, and a positive work-life balance.

Company details

Company typeScaleup
IndustryBusiness Consulting & Services
Company size201 - 500

Links

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Job description

Job Summary: The Senior Manager – Statistics will be responsible for statistical activities across all stages of clinical trials, from protocol development through final study reporting. This role also supports statistical work related to drug in-licensing, regulatory filings, and post-marketing activities. The ideal candidate will bring strong statistical acumen, leadership, and a deep understanding of clinical research standards and regulatory guidelines.
Key Responsibilities:
  • Review clinical trial protocols and contribute to the design of study elements, including sample size calculations, statistical methodology, and timelines.
  • Author and/or review statistical sections of protocols, SAPs, TFL shells, and variable derivation specifications.
  • Review CRFs, database design, and edit check specifications to ensure data integrity and consistency.
  • Monitor study conduct, quality surveillance plans, and data quality throughout the trial.
  • Provide statistical and validation support for data analyses, including analysis datasets and TFLs.
  • Review and contribute to clinical study reports (CSRs), manuscripts, and other statistical documentation.
  • Participate in the preparation of responses to health authorities and perform ad-hoc analyses as required.
  • Provide statistical input to regulatory documents and filings.
  • Collaborate effectively with cross-functional teams, CRO statisticians, statistical programmers, and vendors.
  • Track and manage timelines related to statistical deliverables, proactively mitigating risks.
  • Lead CRO statistical teams, review their deliverables, and ensure compliance with quality standards.
Required Qualifications:
  • Ph.D. in Statistics or Biostatistics with 4+ years of experience, or MS with 6+ years in the pharmaceutical or CRO industry.
  • Proficiency in SAS programming and statistical software.
  • Strong knowledge of industry standards including ICH guidelines, CDISC data structures, and FDA statistical requirements.
  • Proven experience in reviewing CRF designs, database specs, edit checks, and clinical documents.
  • Strong written and verbal communication skills with the ability to present statistical concepts clearly.
  • Excellent organizational, problem-solving, and interpersonal skills.
  • Demonstrated ability to lead CRO teams, and work both independently and collaboratively.
  • Experience contributing to responses for regulatory submissions and health authority queries.
Preferred Attributes:
  • Ability to manage multiple tasks and adapt quickly to changes in project scope or timelines.
  • Strong leadership in cross-functional settings, and comfort with mentoring and guiding team members.
  • Keen attention to detail and quality-focused mindset.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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