Senior Manager, Biostatistics

Blueprint Medicines Corporation Cambridge , MA 02139

Posted 2 months ago

Senior Manager, Biostatistics

Cambridge, MA

Job Req: CLD19-004

At Blueprint Medicines, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-a-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicines to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

Job Summary:

This position is responsible for statistical aspects of study designs, planning and execution of statistical analyses for multiple clinical development programs, health authority submissions, presentations and publications, by working closely with colleagues in clinical development, translational medicine and research, and with key outsourced functions including data management, SAS programming, clinical pharmacology, medical writing, and regulatory affairs to advance Blueprint Medicine's drug candidates under development. This position will serve as the in-house statistical expert and provide statistical consultation to all functions within Blueprint as necessary.

Responsibilities:

  • Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of all sections.

  • Author statistical analysis plans for clinical trials, and author/edit mock tables, listings and figures.

  • Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses.

  • Specify randomization schedules and test their implementations.

  • Work with external statistical programmers and data managers to generate tables, listings and figures.

  • QC the key results of statistical programmers.

  • Support ongoing safety review of the program/study teams and data monitoring committees.

  • Perform ad hoc statistical analyses and basic SAS programming as needed.

  • Contribute to the clinical study reports, including authoring of statistical sections and interpretation of the study results.

  • Support regulatory submissions.

  • Support the preparation of publications, including manuscripts, posters and oral presentations.

  • Provide requirements and oversight to external statistical programmers, data managers and other relevant functions at CROs to ensure quality of deliverables.

  • Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.

  • Provide statistical input on CDP, IDP, and registration plan.

  • Provide analysis support for presentations and publications.

  • Keep abreast of new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.

Qualifications:

  • PhD in statistics or a related field with at least 3 years of clinical trial experience in the pharmaceutical industry, or MS in statistics or equivalent with at least 5 years of clinical trial experience in the pharmaceutical industry. Experience in oncology clinical research is strongly desired.

Capabilities:

  • Knowledge of statistical methods that apply to Phase I-IV clinical trials.

  • Knowledge of FDA and ICH regulations and guidelines.

  • Interaction with regulatory authorities desired.

  • Experience investigating the relationships between biomarkers and clinical endpoints is desirable but not required.

  • Relevant experience partnering with CROs.

  • Proficient in statistical programming (SAS is required, and R is a plus).

  • Experience with trial design software (e.g., EAST); working knowledge of Spotfire is desired.

  • Proven experience concurrently supporting multiple studies, providing timely and scientifically sound statistical expertise as well as exceptional attention and accuracy with the study details.

  • Strong interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills.

  • Self-motivation and self-confidence are critical.

All applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability or protected veteran status.

WHO WE ARE:

Blueprint Medicines' mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don't think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Nonclinical Biostatistics Early Clinical Development

Pfizer

Posted 6 days ago

VIEW JOBS 4/13/2019 12:00:00 AM 2019-07-12T00:00 * Collaborate with preclinical laboratory scientists across research units (Immunology & Inflammation, Internal Medicine, Rare Disease, CTI) to design and analyze experiments. * Summarize statistical analyses in reports and presentations. * Bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Pfizer. * Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed. * Serve as a core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality manner. * Understand the target biology and improve existing biomarkers, endpoints, derive new endpoints, and develop fit-for-purpose statistical models. * Where possible, standardize processes and methodologies within and across therapeutic areas. * Provide statistical expertise on regulatory submissions and ensure quality of deliverables. * MS or PhD in Statistics/Biostatistics, PhD preferred. * Previous preclinical/non-clinical statistics experience is preferred. * Must have strong technical competence in statistical techniques. * Capability to provide statistical leadership to cross-functional teams. * Ideal candidate will understand design of experiments, assay development, and statistical applications for preclinical research. * Strong computational skills in SAS or R. * Strong written and verbal communication skills. * The ability to work collaboratively with research scientists. * Demonstrated ability to work effectively as a part of a team.Interest in biology is essential, bachelor's or graduate-level training preferred. Job Description Pfizer's ECD Statistics is looking for a statistician with an interest in preclinical statistics and collaborating with research scientists in drug discovery and development. The candidate will work closely with laboratory scientists seeking to discover new medicines in a variety of therapeutic areas by supporting the design and analysis of preclinical experiments, covering all aspects of drug discovery from disease target identification, pharmacology studies, animal model development, biomarker development and demonstration of proof-of-concept. The ideal candidate will have a genuine interest in understanding drug target biology to provide effective statistical consultation with biological scientists. ROLE RESPONSIBILITIES * Collaborate with preclinical laboratory scientists across research units (Immunology & Inflammation, Internal Medicine, Rare Disease, CTI) to design and analyze experiments. * Summarize statistical analyses in reports and presentations. * Bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Pfizer. * Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed. * Serve as a core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality manner. * Understand the target biology and improve existing biomarkers, endpoints, derive new endpoints, and develop fit-for-purpose statistical models. * Where possible, standardize processes and methodologies within and across therapeutic areas. * Provide statistical expertise on regulatory submissions and ensure quality of deliverables. QUALIFICATIONS * MS or PhD in Statistics/Biostatistics, PhD preferred. * Interest in biology is essential, bachelor's or graduate-level training preferred. * Previous preclinical/non-clinical statistics experience is preferred. * Must have strong technical competence in statistical techniques. * Capability to provide statistical leadership to cross-functional teams. * Ideal candidate will understand design of experiments, assay development, and statistical applications for preclinical research. * Strong computational skills in SAS or R. * Strong written and verbal communication skills. * The ability to work collaboratively with research scientists. * Demonstrated ability to work effectively as a part of a team. Other Job Details: * Eligible for Relocation Package * Eligible for Employee Referral Bonus Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. N (Other) (United States of America) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Pfizer Cambridge MA

Senior Manager, Biostatistics

Blueprint Medicines Corporation