Celgene Associate Director SDTM, Clinical Programming in Berkeley Heights, New Jersey


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.

Responsibilities will include, but are not limited to:

Programming Leadership:

  • Responsible for supervising Programmers by planning/assigning workload

  • Responsible for performance evaluations and development of direct reports including identifying opportunities for cross functional collaboration

  • Act as a coach/mentor and model behaviors to set examples for programmers, responsible for the overall performance of each of their team members

  • Manages team conflicts to resolution and improved team collaboration

  • Lead/participate in implementation of processes and technologies consistent with strategy

  • Expert at leveraging limited resources for maximum impact on projects and initiatives

  • Monitor and forecast programming resource needs and ensure that projects are sufficiently resourced

  • Monitor projects to ensure consistency and adherence to SOPs and best practices

  • Represent as technical expert who decides best course of action and leverage networks to achieve influence with others

  • Develop Therapeutic Area SDTM programming strategy and collaborate with other functions in regards to programming deliverables e.g. SDTM specifications, submission activities, high level project algorithms

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

  • Experience with standard governance organizations

  • Conduct cross functional meetings to gain trust and respect of team members, makes decisions on business issues, and freely challenges and expresses perspectives

  • Work with CROs at the alliance level to ensure consistency across therapeutic areas and ensure alignment with department/company strategy

  • Work closely with CROs to build/maintain positive relationships, negotiate timelines/budgets, successfully manage conflicts and thoroughly understand the CRO processes

Other Key Activities:

  • Contributes to development and execution of department strategy

  • Develop job descriptions and career paths for programmers

  • Ensure consistency and adherence to standards and governance within their therapeutic area and the department

  • Lead/contribute to the creation, maintenance and validation of standards for programming tools, outputs and macros as well as naming conventions; and offer training on the same

  • Lead/participate in department and/or cross-functional process improvement initiatives, special projects and regularly disseminate information to teams and stakeholders

  • Evaluate and assign resources needed to support initiatives and special projects

  • Independently manage resources and timelines for special projects, and collaborate with other departments and external partners during the execution

  • Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents

  • Represent programming during internal audits as well as Health Authority audits

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

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

  • Build inter-departmental relationships and resolve issues as needed

  • Participate in industry wide technical discussions

Skills/Knowledge Required:

  • Strong knowledge of CDSIC Standards, SDTM, data capture, database design, programming requirements for drug development and regulatory requirements is required, as well as prior experience in managing the programming function

  • BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 9 years of experience as a Clinical Programmer, Statistical Programmer, or SAS Programmer

  • Minimum 5 years of management experience

  • Demonstrates direct and indirect management skills, strong project management skills; good communication skills; ability to work in a cross-functional team environment

  • Expert in CDSIC standards including CDASH or SDTM/ADaM

  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats

  • Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, and data validation

  • Demonstrates expertise in providing outputs to meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission)

  • Demonstrates expertise in the handling and processing of upstream data (e.g., multiple data sources, data workflow, eDC, SDTM)

  • Proficient in programming languages and demonstrates proficiency in using SAS a plus

  • Advanced knowledge of clinical database design and programming practices

  • Knowledge of data management systems (Rave, InForm, or OC RDC) and/or good understanding of SAS datasets and procedures. Familiar with reporting tools (e.g. JReview, SpotFire)

  • In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices

  • Good understanding of clinical data and pharmaceutical development

  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs

Medical or mathematics/computer science background a plus

BA/BS in a relevant scientific discipline; minimum 9 years of experience as a programmer in a pharmaceutical/CRO setting with a leadership role. Regulatory submissions experience with expertise in CDSIC/SDTM

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.