About Servier Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge …
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$164k–$194k/yr
Full-time
postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Flexible Time Off, Unlimited Sick Time, 401(k)
Posted 4d ago
Apply by Dec 1
~40 hrs/week
Remote in United States
Responsibilities
Direct the execution of statistical analyses and provide scientific validity for clinical development plans and regulatory submissions. Partner with cross-functional stakeholders to integrate statistical perspectives into data packages and regulatory meetings.
Requirements
Requires a PhD in Biostatistics with 5+ years of pharmaceutical experience, or a Master's degree with 8+ years of experience. Must possess strong proficiency in SAS and deep knowledge of ICH, FDA, and EMEA regulatory guidelines.
Full job description
About Servier
Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.
Job Description
Role Summary
As a key member of the Global Biometrics Department, the Associate Director, Biostatistics will work on one or more assets or indications, contributing to all statistical aspects of the clinical development plan, individual studies, submissions, or evidence generation activities. This role partners closely with clinical, regulatory and other evidence generation stakeholders to provide quality, regulatory relevance, and scientific validity.
Primary Responsibilities
Provide statistical support on one or more assets or indications by directing the execution of statistical analyses, review of statistical outputs, and ensuring accurate results interpretation, collaborating closely with physicians, evidence generation stakeholders, or other cross-functional leads as appropriate on the interpretation of clinical results
Plan and track activities and timelines across projects; justify resource needs and ensure efficient utilization of available capacity
Provide input into product development, medical affairs or HEOR/HTA strategy by suggesting innovative designs and decision-making tools
Partner with other Biostatistics department members or consultants, to develop effective statistical approaches applicable to project.
Select appropriate statistical methods for study design and data analysis, review protocols and statistical methods and results sections for study reports
In partnership with other Biometrics members, interact with regulatory authority, other external bodies or scientific community on clinical trial statistical issues
Provide guidance to the clinical, regulatory, and/or evidence generation teams on conclusions and inferences from the data package, ensuring statistical perspective is integrated into regulatory and external meetings, and delivering data packages aligned with submission requirements or key decision-making
Responsible for the statistical aspect of regulatory documents such as CSRs, as well as integrated reports and summary documents
Collaborate in departmental process improvement initiatives and development/revision of quality documents
Monitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in compliance
Contribute to publication plan by reviewing abstracts, posters, and manuscripts to support Medical Affairs.
Contribute to the establishment and maintenance of common formats and templates for key Biostatistics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings)
Candidate Profile
Education and Required Skills
Ph.D. in Biostatistics or closely related field is required with a minimum of 5 years of relevant pharmaceutical experience. Master’s degree in Statistics or related field may be considered with minimum of 8 years of experience.
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
Proficiency in SAS is strongly preferred
Ability to determine appropriate designs and analyses for clinical trials and/or evidence generation
Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs as needed
Must have a working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices
Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA) and industry standards applicable to clinical development or evidence generation
Direct regulatory filing experience is preferred for roles supporting clinical development
Ability to respond to regulators or other external inquiries
Ability to take appropriate action in all dealings with CRO partners to ensure best practices are followed
Demonstrated sound judgment and decision-making, with the ability to evaluate business impact, follow through on decisions, and adapt as priorities change
Travel and Location
Some domestic and international travel required
On-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to Boston
Servier’s Commitment
Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Salary Range
The salary range for this role is $164,000-194,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.
Servier Pharmaceuticals is a Boston-based, commercial-stage biopharmaceutical company. As the U.S. subsidiary of Servier Group, Servier is governed by a non-profit foundation, enabling the company to approach innovation with a long-term vision centered on the patient, free of influence from outside investors and short-term market pressures.
Launched in the U.S. in 2018, Servier Pharmaceuticals is focused on advancing innovative therapies in oncology and neurology for patients living with difficult-to-treat diseases. In oncology, the company has built a portfolio of first- and best-in-class medicines designed to bring transformative precision therapies to more patients. Servier is expanding its neurology business with the same commitment to science, partnership, and patient-focused innovation.
At Servier, we bring the patient voice into everything we do. We are dedicated to advancing meaningful therapeutic progress and improving outcomes for the patients and communities we serve.
Offices: 200 Pier Four Boulevard, Boston , MA 02210, US