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Programming Project Ldr Submission Lead
Waltham, MA

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About

Job Description

Responsibilities

Job Scope:

The Leader, Statistical Programming is responsible for driving high standards for individual, team and organizational accomplishments of the Biometrics department. He/She is responsible for overseeing all aspects of recruitment, training and development for department, and ensuring that skills and abilities are in line with future direction and strategies of the Statistical Programming department. He/She is accountable for the timely delivery of Biometrics milestones by ensuring availability of adequate and appropriate resources consistent with Biometrics outsourcing strategies. This person is responsible for development and implementation of strategy, policy, operations management and capability building in Statistical Programming in addition to representing Biometrics for Development initiatives, projects and collaborations. He/She works closely with other Biometrics functional heads to ensure alignment with Biometrics goals and strategy. He/She leverages strategic collaborative relationships throughout the Development organization to influence decision making impacting the Biometrics and Statistical Programming departments.

Key Responsibilities:

* Strategy: Contributes to and implements the operational strategy for his/her Biometrics Functional Group in support of the overarching Biometrics Departmental Strategy
* Execution: Meets portfolio deliverables through project, resource, and operational management including effective- risk mitigation; capacity planning; vendor governance; delivery of technology solutions; and cross-functional communication.
* Process or Technical Improvements: Drives business process development and quality management through input to and implementation of innovative process improvement strategies; development of best practices; and consistent global performance and standard compliant business practices.
* Leadership and Management: Provides leadership in best practices for employee development through talent acquisition and retention; management; and development of departmental staff. Provides leadership and management of personnel in Biometrics Functions, cascading information and goals, and proposing operational strategy/improvements.
* Collaboration and Communication: Develops and leverages strategic collaborative relationships throughout the Development organization to influence decision making impacting Biometrics and Statistical Programming. Leads or represents Statistical Programming in cross-functional initiatives to ensure alignment of best practices within Development functions.



Essential Skills and Qualifications Required:

This incumbent will be a key senior level driver for the implementation of a new strategic approach for the Biometrics and Statistical Programming groups. Requires demonstrated strength in change management of a cross-functional initiative. Core strengths required include Compelling Communication, Driving Execution, Leading Change, Influence, and Cultivating Networks.

Minimum Requirements:

* Bachelor's degree with 10+ years of experience, or Masters or PhD in Statistics or Mathematics with 8+ years of experience
* Experience in a leadership position within an organization with a focus on data management and analysis
* SAS Base programming with 10+ years using SAS STAT, GRAPH and MACRO

Preferred Requirements:

* 12+ years relevant industry experience
* 12+ years clinical trial experience
* 5+ years clinical database experience
* Extensive knowledge of drug development process and clinical trials
* Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines
* Familiarity with other software development packages (S Plus, VB)
* Deep understanding of drug development and biopharmaceutical industry preferred
* Strong management skills, and ability to effectively lead and collaborate with various business functions, Finance, HR, and IT
* High attention to detail including proven ability to manage multiple, competing priorities
* Demonstrated ability to establish effective business relationships with external stakeholders, including vendors.
* Experience managing in a matrix environment and collaborating across functions and organizations, including demonstrated ability to influence without authority
* Ability to successfully implement change management and lead others through change
* Excellent written and oral communication skills
* Demonstrated leadership, problem solving, conflict resolution, and team building 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.

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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.

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