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Ipsen · 1 day ago

Senior Director, Biostatistics

Cambridge, MA

Full-time

Onsite

Director/Executive

$218K/yr - $319K/yr

10+ years exp

Ipsen is a biopharmaceutical company focused on improving patient outcomes through innovative treatments. The Senior Director, Biostatistics will provide statistical expertise and leadership in the development of neuro assets, mentor a team of biostatisticians, and engage with external stakeholders to ensure compliance with industry standards.

BiotechnologyPharmaceuticalProduct Research

H1B Sponsor Likely

Responsibilities

Work as program-level lead biostatistician in cross-functional team(s). Responsible for providing strategic support to Ipsen asset team(s), as well as authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents

Provide strategic leadership and direction within Neuroscience programs, leveraging deep expertise to influence product and/or business strategy

Lead and coordinate the planning and execution of biostatistics deliverables, ensuring quality and adherence to timeline, by collaborating with internal and CRO team members

Make decisions guided by functional, divisional, and enterprise-level priorities, with a direct impact on business outcomes

Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, and statistical analysis interpretation, reporting, and presentation of clinical study results

Evaluate and interpret clinical trial data, prepare slides, and present results to internal and external stakeholders

Provide oversight and guidance to ensure CRO partner understands the nature of the clinical data being collected and the approaches to summarizing the information. Validate and QC CRO’s work to ensure the quality and accuracy of the statistical deliverables

Support the preparation and validation of statistical analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis

Play a critical role in shaping team development through ongoing training, mentorship and career development opportunities, and contribute to departmental strategy

Lead or contribute to high-visibility, cross-functional initiatives of strategic importance, including long term digital and data strategy, refinement of external sourcing, and optimization of internal processes

Qualification

PhD in StatisticsAdvanced statistical methodsSAS programmingClinical study designNeuro drug developmentRegulatory submission experienceCommunicationAttention to detailProject managementProblem-solving skills

Required

10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS; at least 5 years in a leadership role

Advanced knowledge and practical experience of widely used clinical study designs as well as complex study designs

Hands-on familiarity with common and advanced statistical methodology including methods adopted in adaptive design

Expertise in applying, analyzing, reporting, and interpreting both descriptive and inferential statistics

Strong knowledge of SAS programming concepts and techniques in the pharmaceutical, with the ability to proactively address strategic limitations; proficiency in tools such as SAS, R, EAST, nQuery, and JMP

Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets

Excellent communication skills, both written and verbal, with the ability to convey complex statistical concepts clearly across functional areas

Strong attention to detail

Proven ability to collaborate effectively in global, cross-functional, and culturally diverse teams; strong interpersonal and relationship-building skills

Demonstrated initiative, flexibility, and independent problem-solving skills with a proactive, positive approach

Strong project and time management skills

Deep understanding of statistical methodologies, clinical study designs, and the drug development process

Ability to see the big picture while maintaining attention to detail

Ability to manage multiple complex projects and assess resource needs

PhD in Statistics, Biostatistics, Mathematics, or a related quantitative field

Fluent in English, with excellent verbal and written communication skills

Preferred

Neuro drug development experience is highly desired

Regulatory submission (US FDA, EMA, PMDA) experience is highly desired

Benefits

401(k) with company contributions

Group medical, dental and vision coverage

Life and disability insurance

Short- and long-term disability insurance

Flexible spending accounts

Parental leave

Paid time off

Discretionary winter shutdown

Well-being allowance

Commuter benefits

Company

Ipsen

Glassdoor3.7

Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.

Founded in 1929

Boulogne-billancourt, Ile-de-France, FRA

5001-10000 employees

http://www.ipsen.com

H1B Sponsorship

Ipsen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2020 (1)