Senior Dir, Global Biostatistics & Medical Writing

Organization
CSL Behring
Job Location
na
King, PA 19406
Job Description

The Global Head of Analysis & Authoring is a key role within Global Development (GD) and a member of the GD Leadership Team. The Head provides overall leadership for the statistical, programming and medical writing across clinical development programs as pertains to design, analysis, authoring and decision making. The Head is responsible for people leadership, organizational structure and staff development within the Department of Global Analysis and Authoring. The Head will serve as a source of internal advice & consultation to other senior leaders within R&D and the greater overall organization.
The Global Head of Analysis & Authoring is a key role within Global Development (GD) and a member of the GD Leadership Team. The Head provides overall leadership for the statistical, programming and medical writing across clinical development programs as pertains to design, analysis, authoring and decision making. The Head is responsible for people leadership, organizational structure and staff development within the Department of Global Analysis and Authoring. The Head will serve as a source of internal advice & consultation to other senior leaders within R&D and the greater overall organization.
Overall 

•Accountable for strategic and technical aspects of the statistical & authoring contribution to all clinical development programs and to regulatory interactions globally.
•Align with the Therapeutic Area Heads and other stakeholders within CSL to drive great science, innovation, efficient design, high level reporting & submissions and quantitative decision making for development programs.
•Accountable for overall performance, resources, and budget of Biostatistics, Programming & Medical Writing 
The Senior Director, Global Biostatistics and Medical Writing will ensure Biostatistics, Programming & Medical Writing groups are designed to ensure future success across all of Development and that there is alignment with the greater CSL organization

•Align organization to optimize resources and alignment with other Development and Business activities
•Manage the full scope of Biostatistics & Reporting activities in clinical studies, regulatory submissions, and result presentations.
•Govern the quality of statistical analysis and medical writing planning.
•Oversee the quality and timely delivery of Statistical, Programming & Medical writing activities both internal and external via CROs and consultants
•Manage the optimal use of resources within the line of Biostatistics, Writing and Programming in accordance with the CD strategic priorities.
•Ensure the quality of Medical Documents (e.g. CSRs, MAA) help maximize the impact of clinical programs and enhance the likelihood of regulatory success
•Support strategic use of Medical Writing resource when needed to enhance Regulatory interactions
•Support Transparency initiatives within CSL in line with external guidance
•Drive statistical strategy to maximize the likelihood of clinical & regulatory success.
•Ensure the quality of Biostatistics input to regulatory submission documents and result presentations.
•Oversee Biostatistics engagement with regulatory agencies.
•Advocate and facilitate quantitative decision making to optimize clinical development plans.
•Promote state-of-art statistical methodologies into the clinical study design and statistical analyses from first-in-man to post registration. 
Develop and manage the outsourcing strategy for Biostatistics, Writing and Programming.

•Align the outsourcing strategy with the CD business needs and objectives.
•Establish effective CRO governance process.
•Foster collaborative relationship with CROs to ensure external contracting standards and processes are in accordance with the regulations and state-of-art practices and consistent with internal CSL standards.
•Manage external spend on CROs. 
Create, Grow and Sustain a Culture of Biostatistician and Medical Writing Leaders at CSL

•Foster a leadership culture which attracts, develops, and retains a highly skilled and motivated workforce.
•Build a culture of engagement where colleagues understand how what they do is integral to the success of Development and the overall business.
•Foster a spirit of peer working within the department and across departments
•Sponsor professional development of staff; ensure development opportunities for staff are fully explored. 
Establish and maintain strategic capabilities of Biostatistics, Writing and Programming;

•Develop and sustain the internal scientific expertise to meet the business needs
•Continuously raise the quality of the entire staff.
•Maintain knowledge of modern scientific methods through survey of relevant literature, attendance at meetings and use of international external networks, etc.
•Ensure professional staff are actively engaged in external professional societies and conferences
•Consistently employ innovative study designs and the best practices for data analyses and interpretation in order to maximize the value of our medicines.
•Build and maintain a network of world-leading external statistical advisors and consultants. Facilitate input from external statistical experts. 
Drive efficient Biostatistics, Writing and Programming operational processes.

•Lead process improvement.
•Ensure all Standard Operating Procedures are in place and updated to meet the regulatory and GCP compliance requirements.
•Ensure proper representation by department in creation and approval of new SOPs to facilitate the best and most efficient working for the department
•Partner with Data Management to build efficient operational processes.
•Collaborate on process improvement initiatives within Clinical to ensure seamless design, data capture, analysis and reporting  
•Contribute to the Clinical development strategy and progress through participation in relevant committees.
•Identify and promote the next generation opportunities for infrastructure improvement.
•Participate actively in Audits/Inspections related to data quality 



Requirements: 

Position Qualifications and Experience Requirements: 
Education 
PhD or MS in Biostatistics, Statistics, or other related Quantitative fields (i.e. Epidemiology)
Experience  

•At least 10 years in a statistical/quantitative/scientific leading role in pharmaceutical setting.
•Advanced training and experience in the theory and application of the main statistical methodologies.
•Broad knowledge of clinical development from preclinical to post marketing.
•Experience of regulatory submissions and track record of interactions with major authorities.
•Track record of successfully managing large groups within complex global organizations.
•Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.
•Ideally experienced in both large and small pharmaceutical companies 
Competencies

•Must possess excellent interpersonal skills in a multicultural environment.
•Strong communications skills, both written and spoken.
•Interest and willingness to develop people to their maximum ability
•Excellent networking and proactive relationship building ability for successful collaboration with internal and external partners.
•Excellent decision making skills and ability to take appropriate risks.
•Strong influencing skills with the ability to quickly earn credibility across other functional areas.
•Interest in organizational design to optimize organizational effectiveness 
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.
CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.
Worker Type:
Employee
Worker Sub Type:
Regular

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