3 Associate Director Statistical Programming Jobs in Cambridge, MA

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Statistical Project Leader (Associate Director)

Sanofi EU

Cambridge, MA | Full Time

$101k-134k (estimate)

Just Posted

Associate Director Statistical Programming

BioNTech AG

Cambridge, MA | Full Time

$158k-192k (estimate)

3 Weeks Ago

Statistical Project Leader (Associate Director), Biostatistics

Sanofi

Cambridge, MA | Full Time

$105k-134k (estimate)

1 Month Ago

Associate Director Statistical Programming

BioNTech AG Cambridge, MA

$158k-192k (estimate)

Full Time 3 Weeks Ago

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BioNTech AG is Hiring an Associate Director Statistical Programming Near Cambridge, MA

Open for hire at one of the following locations – Cambridge Erie Street, Mainz K1. - Job ID: 7197

Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director Statistical Programming

Responsibilities:

Work with the Director Statistical Programming to implement global statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency.
Support the development and implementation of a global programming ecosystem to enable successful project deliverables.
Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting.
Independently performs or oversees the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries.
Anticipates resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project.
Ensures quality control (QC) performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements.
Participates in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios; develops tools for efficient production and verification of derived datasets, e.g. SDTM and ADaM, and TLFs.
Collaborates with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools.
Provides programming support to the regulatory submissions including data submission package and define.xml development.

Requirements:

Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred.
10 years (5 years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting.
Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
Oncology or infectious disease therapeutic areas and submission experience is preferred.
Project management experience.
Strong understanding of FDA, EMA, ICH, and global regulations and guidelines.
Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards.

Benefits for you

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations –Cambridge Erie Street, Mainz K1. Apply now for your preferred job and location through our careers site.

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!