Top 279 sdtm Jobs | SimplyHired

Senior Director Biostatistics (Oncology)
BioNTech AG —Cambridge, MA
- $198,900 - $318,300 a year
- Full-time
- Background check
- 18 years or older
- English
Director, Biostatistics (Oncology)
BioNTech AG —Cambridge, MA
- $168,100 - $268,700 a year
- Full-time
- Background check
- 5 years
- Master's degree
- Health savings account
- AD&D insurance
Contract Senior Statistical Programmer (Remote)
Sysdata Consulting, Inc —Remote
- From $100 an hour
- Full-time
- Remote
- Computer science
- Computer Science
- Master's degree
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3d
Clinical Data Engineering Lead
Novartis —Cambridge, MA
- $176,400 - $327,600 a year
- Full-time
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Senior Manager, Clinical Programming
Genmab —Princeton, NJ
- $131,040 - $196,560 a year
- Online Application
- Computer science
- 6 years
- Computer Science
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Senior Programming Manager
Genmab —Plainsboro, NJ
- $128,080 - $192,120 a year
- Online Application
- Computer Science
- Master's degree
- 8 years
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- Paid parental leave
Director Biostatistics - Oncology
Penfield Search Partners —San Francisco, CA
- Doctor of Philosophy
- Contracts
- Budgeting
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Senior Manager, R&D Data Stewardship
CSL Behring —King of Prussia, PA
- Full-time
- Computer Science
- 5 years
- Master's degree
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Senior Data Validator, Clinical Oversight & Standards
CSL Behring —King of Prussia, PA
- $143,000 - $169,000 a year
- Full-time
- Hybrid work
- Computer Science
- 5 years
- Bachelor of Science
Director, Biostatistics
Kaztronix —Miami, FL
- Contract
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- Travel
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Senior Bioinformatics Data Engineer
Kaztronix —Wilmington, DE
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- 5 years
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Principal Statistical Programmer
Clinvia LLC —San Francisco Bay Area, CA
- From $66.81 an hour
- Contract
- Hybrid work
- Bachelor of Science
- 8 years
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4d
Associate Director - External Data Acquisition Lead (EDAL)
Genmab —Plainsboro, NJ
- $157,360 - $236,040 a year
- Online Application
- Master's degree
- Bachelor's degree
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Director, Late Development Statistical Programming
Genmab —Princeton, NJ
- $186,880 - $280,320 a year
- Online Application
- Computer science
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- 11+ years
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- Paid parental leave
Associate Director Oncology Biostatistics
Penfield Search Partners —San Francisco, CA
- 5 years
- Doctor of Philosophy
- Quality control
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Director/Senior Director, Biostatistical Programming
Kaztronix —Gaithersburg, MD
- Computer Science
- 11+ years
- Mentoring
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10d
Associate Director, Statistical Programming
Everest Clinical Research —Bridgewater, NJ
- $170,000 - $205,000 a year
- Remote
- Computer Science
- 11+ years
- Databases
- AD&D insurance
- Disability insurance
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FSP Principal Statistical Programmer (Remote)
Everest Clinical Research —Bridgewater, NJ
- $112,000 - $175,000 a year
- Remote
- Computer Science
- Doctor of Philosophy
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Clinical Data Manager /Data Analyst (Remote)
Penfield Search Partners —Fairfield, CT
- Contract
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- 5 years
- Bachelor of Science
- SQL
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Associate Director, Biostatistics
Genmab —Princeton, NJ
- $156,880 - $235,320 a year
- Online Application
- Master's degree
- Databases
- Doctor of Philosophy
- Commuter assistance
- Paid parental leave

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Senior Director Biostatistics (Oncology)

BioNTech AG -
Cambridge, MA

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Job Details

Full-time
$198,900 - $318,300 a year

Qualifications

FDA submissions
Staff supervision
Biostatistics-based research
Scientific publications
Professional ethics
Risk mitigation strategy development
English
Research project design
ICH guidelines
Statistics research
Pharmaceutical company experience
Managing clinical research teams
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Oncology
Cross-functional collaboration
Clinical data analysis
Clinical trial support in drug product development
Pharmaceutical research
Cross-functional communication
Data analysis software
Senior leadership

Full Job Description

London, United Kingdom; Cambridge, US; Mainz, Germany; Munich, Germany | full time | Job ID: 11336

About the role:

As Senior Director of Biostatistics you will represent Statistics in all assigned cross-functional clinical study teams and other projects. You will be accountable for all statistical aspects as well as serve as the biostatistics lead core team member for all assigned programs representing Statistics in multiple projects of cross-functional process and standards development/improvements, infrastructure initiatives and evaluations.

Your main responsibilities are:

Provide statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
Work as part of a collaborative, cross-functional team with members from other disciplines
Perform and/or verify sample size calculations
Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
Support and participate in the development of departmental strategies, and cross functional initiatives on standards/ infrastructures/ processes
Support and assist GBS Lead in both strategy developments and operations
Assumes possible line management responsibilities of staff and is responsible for recruiting, developing, and retaining talent
Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met

What you have to offer:

PhD or Masters in (Bio)Statistics, Mathematics or equivalent
Minimum 15 years (18 years for masters) in the pharmaceutical industry and/or CRO
At least 10 years of work/ leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
Experience in planning, conducting and analyses of oncology or infectious diseases trials from phase I-IV, including scientific publications
Experience in leading to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages
Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
Excellent knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
Very deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
Outstanding analytical skills and ability to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues
Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors
Excellent communication skills:
- the ability to express complex analysis in clear language
- an excellent command of English written spoken

Your benefits and remuneration:

If the position is filled in the US, the Senior Director Expected Pay Range is $198,900/year to $318,300/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Compensation at other locations may vary significantly.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Apply Now

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