Associate director Work, Jobs in Pitstone, Bkm (with Salaries)

Associate Director, Biostatistics (2)
CSL Behring —Maidenhead
- Full-time
- Doctoral degree
- English
- Leadership
Associate Director - QMS Manager
Lonza —Slough
- Full-time
- Continuous improvement
- Mentoring
- Leadership
Associate Relationship Manager – Mid Markets - Midlands and East England
Lloyds Banking Group —Milton Keynes
- From £40,824 a year
- Full-time
- Hybrid work
- Organisational skills
- IT
- Financial services
12d
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Operations Manager
Active Care Group —Thame
- Full-time
- Annual leave
- Employee assistance programme
Quick apply
6d
Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Travel
- In-person
2d
Capital Markets Associate
Enra Specialist Finance —Watford
- Bachelor's degree
- Communication skills
- Annual leave
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Associate Director- Transport Development Planning
Steer —Hemel Hempstead
- Full-time
- Hybrid work
- Business development
- Mentoring
- Annual leave
- Employee assistance programme
Quick apply
Associate Director, Senior Environmental and Social Advisor (Infrastructure)
European Bank for Reconstruction and Development —London
- English
- Mentoring
- Organisational skills
6d
Associate Director, Structural Engineer - Water
AECOM —St Albans
- Full-time
- Hybrid work
- No degree
- Communication skills
Associate Director, Clinical Data Management
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- In-person
Principal Banker
European Bank for Reconstruction and Development —London
- Part-time
- Computer literacy
- English
- Microsoft Office
Senior Director - Assistant Global Controller
Cytiva —Little Chalfont
- Full-time
- Annual leave
Associate Dentist (Visa sponsorship available!)
Damira Dental Studios —Bicester
- £120,000 - £250,000 a year
- Full-time
- In-person
- Relocation assistance
- Referral programme
Quick apply
Private GP - St Albans
Well Life Clinic —St Albans
- £90 an hour
- Part-time
- BLS Certification
- Administrative experience
- Bachelor's degree
Quick apply
Work Winning Lead - Water
AECOM —St Albans
- Full-time
- Hybrid work
- Analysis skills
- Leadership
Principal, PODD
European Bank for Reconstruction and Development —London
- Management
- Contracts
- Communication skills
Associate Director, Data Science
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Azure
- Management
- Doctoral degree
Associate Director, Medical Affairs
Gilead Sciences —Uxbridge
- Full-time
- Doctoral degree
- Analysis skills
- Travel
6d

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Associate Director, Biostatistics (2)

CSL Behring -
Maidenhead

Apply Now

Job details

Full-time

Qualifications

Clinical research
Doctoral degree
SAS
R
English
Leadership
Communication skills

Full job description

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Biostatistics

Job Type: Full Time

Location: Maidenhead, United Kingdom

Employer Reference: R-263047

Job Description

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. ( Positions available supporting multiple Therapeutic Areas available )

Main Responsibilities:

Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
Support or lead improvement initiatives within the department, organization and/or pharma industry.
Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.

Education and Experience:

PhD with 8 years of experience or MS with 11 years of experience in drug development
Experience providing statistical leadership at compound/indication level
Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
Solid experience in applications of advanced statistical methodologies
Leading roles in regulatory submissions
Experience in interactions with major regulatory authorities preferred
Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
Track record of innovation preferred

Competencies:

Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes
Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English)
Good working knowledge of SAS and/or R
Expertise in a range of statistical methodologies
Demonstrated use of innovative / creative methodology for analysis of clinical data
Familiarity with relevant regulatory guidance documents

Expertise in:

CDISC, statistical programming, and/or data standards
Biostatistics and Statistical Programming Operations

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

Refine Your Search

associate director jobs in pitstone, bkm

Associate Director, Biostatistics (2)

Associate Director - QMS Manager

Associate Relationship Manager – Mid Markets - Midlands and East England

Associate Director Global CMC QU – Clinical GMP/GDP

Operations Manager

Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology

Capital Markets Associate

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director- Transport Development Planning

Associate Director, Senior Environmental and Social Advisor (Infrastructure)

Associate Director, Structural Engineer - Water

Associate Director, Clinical Data Management

Principal Banker

Senior Director - Assistant Global Controller

Associate Dentist (Visa sponsorship available!)

Private GP - St Albans

Work Winning Lead - Water

Principal, PODD

Associate Director, Data Science

Associate Director, Medical Affairs

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About CSL Behring

Our Benefits

You Belong at CSL

Equal Opportunity Employer

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