Senior Manager, Biostatistics, Early Clinical Development

Pfizer Cambridge , MA 02138

Posted 2 weeks ago

ROLE SUMMARY

Responsible for ensuring sound statistical thinking and methods are utilized in the discovery and development of new biomarkers. Bring the principles of objective decision-making into the development, validation and implementation of industry-leading mobile/digital technology programs for incorporation into clinical trials. Integral member of a matrixed team, which develops and uses computational and statistical approaches to discover and validate digital biomarkers.

ROLE RESPONSIBILITIES

  • Collaborate with various scientists in the design, analysis and reporting of clinical experiments.

  • 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 to meet clear objectives

  • Core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality environment.

  • Interact with internal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types.

  • Bring innovative statistical thinking and methods to help drive data-driven drug discovery and development employing modern methods including Bayesian techniques

  • Work with scientists to understand the biology and improve existing or derive new endpoints, utilize prior information, develop 'fit-for-purpose' statistical models

  • Use statistical expertise to prepare both internal and external reports, presentations, manuscripts

QUALIFICATIONS

MSc (PhD preferred) in Statistics, Biostatistics or in quantitative discipline such as Physics, Applied Mathematics, Bioengineering, Electrical Engineering coupled with high level of statistical expertise. Research experience with mathematical/statistical modeling using complex data and five or more years of postdoctoralor industrial experience are preferred.

  • Strong background in experimental design and statistical analysis including good understanding of inference and probability, competence in contemporary linear and predictive modeling including (longitudinal) mixed models, nonlinear regression, and predictive modeling

  • Pharmaceutical applications desired, with early clinical (phase I and phase II) and translational experience a definite advantage.

  • Expert level knowledge of machine learning algorithms with robust feature selection and optimization

  • Knowledge of methods of signal processing including image segmentation and/or electrophysiological data analysis

  • Genuine interest in biology and pharmaceutical development, with the attitude of self-directed scientist; demonstrated ability to multitask

  • Outstanding communication skills; ability to explain statistical and modeling concepts to non-experts

  • Demonstrated ability towork effectively as a part of a team

  • Technical Skills

  • Fluency in R programming

  • Programming in Python is a plus

  • Knowledge of MATLAB is a plus

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.

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.

Other Job Details:

  • Last Date to Apply for Job: October 15, 2018

  • Eligible for Relocation Package: yes

  • Eligible for Employee Referral

    Bonus:
    yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

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
Biostatistics Associate Director Oncology Early Development Cambridge MA

Sanofi

Posted 2 days ago

VIEW JOBS 1/16/2019 12:00:00 AM 2019-04-16T00:00 Position Title Associate Director, Oncology Biostatistics Building on its strong heritage, Sanofi takes the opportunity to present new, early-stage studies highlighting an emerging and dynamic portfolio that encompasses diverse strategies in oncology. With fast growing pipeline in oncology early development, this position will play a very important role to provide statistical leadership in the clinical development. Job overview Provide leadership and guidance as the lead statistician on a project team in Oncology. For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for project staffing, resource planning and allocation within therapeutic area(s). In some cases incumbent could serve as department leader in specific technical area. Responsibilities * Project - With minimal direction from departmental management, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of clinical studies and submissions of the project: provide innovative and high quality statistical support for creation of clinical development plans (CDP), study design, analyses and operational aspects. Design and execution of CDPs consistently meeting internal guidelines and regulatory requirements. Maintain awareness of industry standards and regulatory requirements and novel methodologies/technologies. * Mentor people working on the project. Promote teamwork, quality, and innovation. Ensure project team compliance with SOPs and departmental standards. * Resource Management - Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload. * Collaboration - Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership. * Represent statistical group in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards. Requirements & Qualifications * PH.D. (MS) in statistics or related discipline with 6+ (8+) years of pharmaceutical experience, including experience in oncology clinical development * Proven success, through previous submissions or significant interactions, in meeting regulatory guidelines and requirements for drug development * 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 * Demonstrated project management, interpersonal skill * Excellent verbal, writing, and presentation skills Location information Cambridge preferred. Bridgewater possible. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Apply For Role My Candidate Account Sanofi Cambridge MA

Senior Manager, Biostatistics, Early Clinical Development

Pfizer