Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Associate Director, Statistics

Expired Job

Celgene Corporation Berkeley Heights , NJ 07922

Posted 3 months ago

Associate Director, Statistics

Req #: 1802933

Location: Berkeley Heights, NJUS

Job Category: Clinical Operations

Work Location: 300 Connell Dr BERKELEY-300 7922

Organization: Celgene Corporation

Schedule: 40

Shift:

Employee Status: Full time

Job Type: Regular

Job Level:

Travel:

Other Locations:US- NJ- Berkeley Heights- 300

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.

Ph.D. in Statistics with 8+ years (or 10+ years for MS) pharmaceutical experience as a statistician supporting clinical trials.

Responsibilities will include, but are not limited to, the following:

  • Actively provide statistical support to Celgene Research and Development

  • Serves as the global lead statistician in the support of trial Phases I-III of drug development for a therapeutic area

  • Manages multiple studies within an indication or therapeutic area.

  • Serves as an advisor to statisticians assigned to the project to ensure high quality and timely deliverables

  • Guides global staff in the preparation of Statistical Analysis Plans. Shepherds the plan through clinical review to ensure worldwide organizational acceptance of the statistical design, endpoints, and proposed analyses

  • Ensures consistency and adherence to standards within a projec

  • Contributes to Clinical Development Plans, submissions and post-submission strategies, preparations and defense, ensuring quality and timing thereof

  • Provides statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned

  • Contributes to, and provides training on new departmental statistical topics, SOPs, WPs

  • Impacts directly on overall business and Biostatistics performance through the ability to influence and work in a consultative manner with senior stakeholders

  • Sets project level priorities

  • Manages resources to meet project team timelines.

  • Escalates issues to functional management as necessary

  • Makes recommendations or resolves technical, quality, and timeline issues

  • Manages outside CROs and contractors

  • Recommends external statistical experts for consultation

  • Provides guidance to employee's development plan and carries out performance review and feedback

  • Evaluates the effectiveness of Biostatistics programs, policies, and processes to meet evolving stakeholder needs

  • Leverages best practices in Biostatistics management to enhance efficiencies

  • Provides directions to project teams using statistical expertise and project knowledge

  • Manages team conflicts to resolution and improved team collaboration

  • Maintains close collaboration and working relationships with stakeholders

  • Manages conflicts with external partners/customers.

  • Represents Biostatistics function at cross-functional meetings

  • Oversees/coordinates biostatistical activities on global submission teams.

  • Partners with senior line management to shape Biostatistics strategy in alignment with the business strategy

  • Works closely with stakeholder leaders to develop and implement high impact business initiatives

  • Leverages existing Biostatistics programs, policies, and procedures to create value-added solutions for Biostatistics

  • Provides proactive expertise, coaching, and counseling to stakeholder leaders, employees, and peers on complex Biostatistics and stakeholder issues

  • Sought out thought leader, providing coaching and mentoring to peers, Statisticians/Programming team members and others

  • Provides continuous feedback to peers and leaders

  • Proactively seeks ways to gain broader experience/perspectives and focuses on a robust professional development plan

  • Leads cross-functional collaboration and conducts meetings to gain the trust and respect of members, make decisions on business issues and freely challenges and expresses opinions may manage and or develop staff; provide coaching and mentoring, monitors other's performance, makes recommendations on resource allocations and provides feedback via formal/informal appraisals

Skills/Knowledge Required:

  • Ph.D. or MS in statistics (or related field) with a focus on statistical methods appropriate for clinical trials.

  • Experience in clinical drug development: 8+ years for Ph.D., 10+ years for MS. Experience in the relevant therapeutic areas is preferred.

  • Demonstrated skill in the planning, analysis and reporting of clinical trials.

  • Detailed knowledge of statistical methodologies, relevant therapeutic areas, and statistical regulatory requirements.

  • Previous experience in leading and completing a task force or supervising statisticians

  • Abreast of clinical trial design concepts.

  • In-depth knowledge of all phases of the drug development process

  • Demonstrated ability to work in a team environment with clinical team members.

  • Good interpersonal, communication, writing and organizational skills

  • Abreast of statistical method development and able to decide on the optimal methods acceptable to regulatory agencies

  • Abreast of relevant project area's clinical trial development and regulatory requirements.

  • Establishes performance standards and commits to evaluation and review of developmental opportunities.

#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.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Sdtm Clinical Programming

Celgene Corporation

Posted 1 week ago

VIEW JOBS 11/8/2018 12:00:00 AM 2019-02-06T00:00 Associate Director SDTM, Clinical Programming Req #: 1803933 Location: Berkeley Heights, NJUS Job Category: Information Technology Work Location: 300 Connell Dr BERKELEY-300 07922 Organization: Celgene Corporation Schedule: 40 Shift: Employee Status: Full time Job Type: Regular Job Level: Travel: Other Locations:US- NJ- Berkeley Heights- 300 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. 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. Celgene Corporation Berkeley Heights NJ

Associate Director, Statistics

Expired Job

Celgene Corporation