Senior Biostatistician | Regulatory Strategy & Clinical Development

Evidencia Scientific Search and Selection Limited; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

Evidencia Scientific Search and Selection Limited is seeking a Senior Biostatistician to lead statistical strategy across clinical development and regulatory submissions in the US. This role involves advising on trial design, analysis, and interpretation while coordinating SAPs and CDISC SDTM/ADaM workflows.

You will mentor junior staff and collaborate with RWE/HEOR and market access teams, translating complex results into client-ready recommendations in a dynamic consulting environment.

Qualifications

• Hands-on pharmaceutical/biotech clinical-development experience, ideally spanning Phase II/III.
• Experience contributing statistical expertise to major regulatory submissions.
• Strong knowledge of SAPs, TLFs and CDISC-compliant SDTM/ADaM datasets.
• Confident communicator for client-facing advisory role.

Responsibilities

• Provide statistical expertise across clinical development and FDA/EMA regulatory submissions.
• Advise on clinical trial design, analysis strategy and interpretation of results.
• Lead statistical workstreams, including SAPs and regulatory analytical deliverables.
• Work across clinical-trial and real-world evidence datasets.
• Mentor junior colleagues and collaborate with multidisciplinary teams.
• Translate complex statistical findings into clear, actionable client recommendations.

Skills

Biostatistics

Regulatory submissions

Clinical trial design

SAPs

CDISC SDTM/ADaM

Client-facing advisory

Education

Advanced degree in Biostatistics or related field

Job description

*New opening* Senior Biostatistician | Regulatory Strategy & Clinical Development

US based - multiple offices and remote considered (Boston HQ/many employees working hybrid)

I’m partnering with a leading international consulting firm on a senior opportunity for an experienced biostatistician looking to take their clinical development and regulatory expertise into a more strategic, client-facing environment - working with a cross functional RWE/RWD, HEOR & Market Access team.

This is an opportunity to work on complex, high-impact pharmaceutical and biotech challenges, supporting clinical development, regulatory submissions and evidence-generation strategy across a diverse portfolio of clients and therapeutic areas.

The role will involve:

• Providing statistical expertise across clinical development and FDA/EMA regulatory submissions.
• Advising on clinical trial design, analysis strategy and interpretation of results.
• Leading statistical workstreams, including SAPs and regulatory analytical deliverables.
• Working across clinical-trial and real-world evidence datasets.
• Mentoring junior colleagues and collaborating with multidisciplinary teams.
• Translating complex statistical findings into clear, actionable recommendations for clients.

The ideal profile:

• Advanced degree in Biostatistics, Statistics, Epidemiology or a related quantitative discipline.
• Hands-on pharmaceutical or biotech clinical-development experience, ideally spanning Phase II/III trials.
• Direct experience contributing statistical expertise to major regulatory submissions (having the blend of strategic and technical expertise is vital)
• Strong knowledge of SAPs, TLFs and CDISC-compliant SDTM/ADaM datasets.
• Confident communicator with the technical credibility and judgement to operate in a client-facing advisory role.

Prior consulting experience is not essential. Candidates from pharmaceutical, biotech and CRO environments are encouraged to explore the opportunity.

If you’re someone who understands the statistical decisions underpinning pivotal trials, primary endpoints, randomisation, sample size and power, estimands, and integrated clinical safety and efficacy packages - I’d love to speak with you!

Why consider it?

The chance to apply your technical expertise beyond a single organisation or product portfolio, influence high-stakes development decisions and work alongside specialists across Market Access/HEOR, biostatistics, clinical research, RWE, epidemiology and regulatory strategy.