CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Associate Statistical Project Leader (Sr. Manager

Company: Sanofi
Location: Cambridge
Posted on: February 24, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the--Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our--colleagues will explain how these tools will be used throughout the recruitment process and will be on hand to answer any questions you might have. Associate Statistical Project Leader (Sr. Manager) From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner. Do you have what it takes for a successful career with Sanofi? Lead one or several late phase studies (incl. Onco early development and MA); lead one or several standard non-Onco early development projects, under minimum supervision of statistical project leader and/or team leader. Major Duties and Responsibilities Provide support and leadership to the clinical trial study and/or project team on all relevant statistical matters: Provide high quality input into the design of the clinical study ( including protocol development) and/or clinical development plan (CDP) for early phase project, the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses. Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables). Accountable for statistical aspects of clinical development plan an strategy for standard nononcology early development projects. Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC). Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties. Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs. Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Review submission documents, such as IND, NDA, BLA, CTD to insure statistical validity and accuracy --- Contribute to define and review the specific deliverables related to Transparency and Disclosure --- Provide technical guidance to junior staff. Plan and track study/project activities and timelines. Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation. Represent statistics to participate in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards. Required Education/Experience: PhD/MS in statistics or related discipline with at least 3 years of pharmaceutical experience Good knowledge of pharmaceutical clinical development, together with Late Phase and/or early Phase experience Broad knowledge and good understanding of advanced statistical concepts and techniques Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (R, ---) Demonstrated strong interpersonal and communication skills 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. Join our Talent Network and get Sanofi communications delivered to your inbox. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Sanofi.

Keywords: Sanofi, Cambridge , Associate Statistical Project Leader (Sr. Manager, Executive , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


CFO/Director of Operations
Description: Chief Financial Officer/Director of Operations Independent, results oriented, innovative---does this sound like you Are you looking for a place where you can help drive innovation, change and results (more...)
Company: Valdez International Corporation
Location: Plymouth
Posted on: 02/25/2021

Associate Cloud Security Architect Director
Description: Associate Cloud Security Architect Director Primary Location: Plymouth Meeting, Pennsylvania, United States Additonal Locations: Durham, NC Full time R1175351 Date Posted: 01/15/2021 The Senior Cloud (more...)
Company: IQVIA Argentina
Location: Plymouth
Posted on: 02/25/2021

Assistant General Manager
Description: Enjoy job stability with Team Car Care as an Essential Business APPLY TODAY IMMEDIATELY HIRING WITH A 1000 SIGN ON BOUNS Safety is our priority COVID-19 protocols are in place Team Car Care owns (more...)
Company: Jiffy Lube
Location: Leominster
Posted on: 02/25/2021


Sr. Director, Quality, Safety, Regulatory Affairs
Description: Sr. Director, Quality, Safety, Regulatory Affairs Position at UMass Memorial HealthAlliance-Clinton Hospital At UMass Memorial Health Care, Everyone is a Caregiver regardless of title. Exceptional patient (more...)
Company: UMass Memorial HealthAlliance-Clinton Hospital
Location: Leominster
Posted on: 02/25/2021

Senior Director, Global Regulatory Affairs
Description: Experience the joy of curiosity, search for a job Click here for additional search options Senior Director, Global Regulatory Affairs A career with EMD Serono is an ongoing journey of discovery: our (more...)
Company: Merck
Location: Billerica
Posted on: 02/25/2021

Senior Program Manager
Description: Sorry, the job you are trying to apply for has been filled. br Searchhere --to view current openings. PLAN FOR SUCCESS CAREER OPPORTUNITIES Our business encompasses many different functions and capabilities, (more...)
Company: Abbott Laboratories
Location: Plymouth
Posted on: 02/25/2021

Client Services Manager
Description: About Agero:Agero is a leading provider of vehicle driver and safely, security and information services including roadside assistance, consumer affairs and claims management services. The company protects (more...)
Company: Agero, Inc.
Location: Medford
Posted on: 02/25/2021

Assistant General Manager
Description: Location 16875 Country Rd 24, Plymouth, MN 55447, United States of America Category Restaurant Managers Job Id JR0022180 Want to work in a place where you feel welcome and you know you belong Looking (more...)
Company: Panera Bread Company
Location: Plymouth
Posted on: 02/25/2021

DIRECTOR- SPECIALTY SALES (Southeast or MidWest
Description: Job Description - DIRECTOR- SPECIALTY SALES Southeast or MidWest 132176 DIRECTOR- SPECIALTY SALES Southeast or MidWest - 132176 Location: Southeast or Midwest area. BASIC FUNCTION Responsible for (more...)
Company: CTI Education Group
Location: Plymouth
Posted on: 02/25/2021

Sr. Manager, Clinical Site Lead (St. Louis, Kansas City
Description: Experience the joy of curiosity, search for a job Click here for additional search options Sr. Manager, Clinical Site Lead St. Louis, Kansas City A career with EMD Serono is an ongoing journey of discovery: (more...)
Company: Merck
Location: Billerica
Posted on: 02/25/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds