Celgene Associate Director, Statistical Programming in Berkeley Heights, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

DEPARTMENT

Biostatistics and Statistical Programming

PREREQUISITES

BA/BS in a relevant scientific discipline; minimum 8-10 years experience as a programmer in a pharmaceutical/CRO setting with a leadership role. Strong knowledge of data processing and programming requirements for drug development is required, as well as strong knowledge of regulatory requirements and prior experience in managing the programming function.

Responsibilities will include, but are not limited to:

Programming Leadership:

  • Responsible for supervising Programmers by planning/assigning their workload

  • Act as a coach and mentor to Programmers

  • Provide training and continued feedback to new programmers to ensure they understand Celgene standards and processes

  • Heavily contributes to development and execution of group strategy

  • Model behaviors, implement new technologies consistent with strategy

  • Proactively anticipate problems, identify root causes and implement creative solutions

  • Leverage networks to achieve influence with others

  • Influence other functions and represent as technical expert

  • Represent as internal team leader who decides best course of action

  • Responsible for performance evaluations and development of direct reports

  • Responsible for development of performance metrics

  • Partner with staff to create individual development plans

  • Monitor changes in project and study resource needs over time and recruit accordingly

CROs and consultant Oversight:

  • Mentor Programmers on CRO database process

  • Monitor progress of database activities in CROs working on Celgene-sponsored studies

  • Participate in Study Team meetings as needed to provide programming expertise and creative solutions to problems

    Other Key Activities

  • Author, review and approve SOPs and Working Practices for the department

  • Streamline interface between departments and troubleshoot issues

  • Assist in developing job descriptions for department including roles utilizing new technologies

  • Direct report responsibility for higher level Programmers

  • Monitor the projects to ensure that SOPs are properly followed, and documentation is available

  • Contribute to the development and maintenance of the statistical computing environment to support global usage

  • Oversee the creation, maintenance, and validation standards for programming tools, outputs, and macros

  • Provide training and continuous feedback to new statistical programmers to ensure their proficiency with Celgene standards and processes

  • Conduct special projects as assigned

  • Seek and continually implement best practices

  • Participate in industry-wide technical discussions.

Skills/Knowledge Required:

  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 8-10 years experience as a programmer

  • Demonstrated management skills and direct management experience required

  • Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers

  • Knowledge of FDA/ICH guidelines and industry standard practices regarding data capture, clinical data structure, relational database, data processing, analysis programming, and data exchange with alternate formats

  • Medical or mathematics/computer science background a plus

  • Knowledge of SAS to produce derived analysis datasets and TFLs.

  • Understanding of the requirements for SDTM, ADaM, Data Definition Table, and e-submission

  • Knowledge of statistical terminology, clinical tests, medical terminology and protocol design

  • Experience managing programmers, preferred

  • Proficient in programming languages / software

  • Advanced knowledge of reporting tools

  • Good understanding of clinical data and pharmaceutical development

  • Ability to research new technologies and ensure alignment with regulatory agencies and industry standards

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.