Associate Director, Biostatistics

Ipsen

  • Cambridge, MA
  • Permanent
  • Full-time
  • 1 month ago
Title: Associate Director, BiostatisticsCompany: Ipsen Innovation (SAS)About Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at and follow our latest news on and .Job Description:WHAT - Summary & Purpose of the PositionThe Associate Director of Biostatistics provides strategic statistical leadership across clinical trials, serving as the subject matter expert in study design, planning, and analysis. This role guides key activities including protocol development, sample size estimation, statistical analysis planning, and in-trial data reviews. It also oversees data quality, supports the generation of tables, listings, and figures, and ensures compliance with CDISC standards and regulatory requirements.In addition to managing internal teams and external partners, the Associate Director plays a pivotal role in preparing statistical components of regulatory submissions. Operating independently, this position ensures statistical rigor and collaborates cross-functionally to support sound clinical and regulatory decision-making.WHAT - Main Responsibilities & Technical Competencies
  • Serve as the lead biostatistician at the study level, authoring and reviewing key documents including protocols, statistical analysis plans, dataset specifications, clinical study reports, publications, and regulatory submissions.
  • Collaborate cross-functionally and with CRO partners to plan and execute biostatistics deliverables with high quality and within timelines.
  • Provide oversight and guidance to CROs, ensuring a clear understanding of clinical data and statistical methodologies; validate and QC their work to ensure accuracy.
  • Support regulatory submissions and scientific publications through preparation and validation of statistical analyses. Support internal ad-hoc and exploratory analysis.
  • Represent Biostatistics in regulatory interactions, including briefing document preparation and participation in meetings.
  • Contribute to the development and refinement of departmental standards, processes, and best practices.
  • Stay current with regulatory guidance, industry trends, and methodological innovations in biostatistics.
HOW - Knowledge & ExperienceKnowledge & Experience (essential):
  • Minimum of 8+ years of relevant clinical biostatistics experience in the pharmaceutical, biotech, or medical device industry with a Master’s degree, or 6+ years with a Ph.D. (or equivalent).
  • Proven experience in clinical development and regulatory submissions.
  • Demonstrated ability to implement state-of-the-art statistical approaches in the design, execution, and evaluation of clinical trials.
  • Demonstrated expertise in advanced statistical methods, including innovative trial designs, endpoint strategies, survival analysis, and approaches for handling missing data and multiplicity.
  • Expertise in SAS and R programming for data management, analysis, visualization, and generation of clinical trial outputs.
  • Strong command of statistical and data management principles applied to clinical research, with a solid understanding of regulatory standards (e.g., GCP, ICH, CDISC).
  • Excellent strategic-thinking and problem-solving skills, with the ability to proactively identify and address complex issues.
  • Effective communicator with strong verbal, written, and presentation skills; able to influence and engage senior stakeholders across functions and geographies.
  • Demonstrated leadership in stakeholder management, negotiation, and guiding teams through complex decision-making scenarios.
  • Strong project and time management skills, with the ability to lead multiple complex projects and assess resource needs.
  • Self-directed and resourceful, with the ability to evaluate alternatives, take initiative, and communicate recommendations clearly.
  • Proficient in MS Word, Excel, and PowerPoint.
  • Ability to represent biostatistics in strategic discussions with clinical and regulatory key opinion leaders, including advisory boards and expert consultations.
  • Skilled in making sound, well-supported decisions in ambiguous or high-impact situations.
  • Capable of setting priorities, driving execution, and leading teams to achieve strategic objectives efficiently.
  • Strong interdisciplinary knowledge with the ability to collaborate effectively across biometrics, clinical operations, medical writing, regulatory affairs, IT, and external partners to drive strategic alignment and execution.
Education / Certifications (essential):
  • Master’s degree
  • Ph.D. (or equivalent degree) is strongly preferred.
Language(s) (essential):
  • Fluent in English is required.
  • French is a plus.
Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.All Employees are expected to adhere to all company policies and act as a role model for company values.The annual base salary range for this position is $143,250-$210,100.This job is eligible to participate in our short-term incentives program.At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.#LI-Remote#LI-MC1IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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