Associate Director, Statistical Programming

Company: Disability Solutions
Location: Irvine
Posted on: March 17, 2023

Job Description:

• SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to thepharmaceutical industry. Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routinesituations.Standards: Oversees effort to determine and implement global company standards related to output design and programming conventions.Responsible for monitoring regulatory guidance and industry best practices.
• Case report forms and database definitions: Provides strategic guidance on the development of CRFs and database designs. Providesin-depth critical review of global standards related to CRF designs and database designs.Derivation Programming, Submission Data Sets and Programs: Demonstrated proficiency in interpreting statistical analysis plans anddeveloping analysis data set specifications. Oversees effort to determine and implement global company standards related to derive datasets and subm
• Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas.Demonstrates an understanding of drug development principles. Anticipates potential problems within and across projects and developsappropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels. Participates inand is viewed as a key contributor to cross functional initiatives.
• Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logicalarguments to other statistical programmers, statisticians, scientists and non-scientists.Effectively presents information through planning and execution of meetings and presentations.
• Training and Mentoring: Provides appropriate background and motivation to staff. Arranges appropriate training opportunities for staff tofacilitate their timely career development. Ensures that self and staff are compliant with training requirements. Effectively mentors statistical programming staff with regard to functional operations.
• Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewingactivities/progress so that projects are delivered on time with suitable quality.Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects. Works collaborativelywith the statistical programming management team to assess project resource requirements versus current staff
• Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceedthose goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honestcommunication where all are encouraged to express their views. Provide all performance management activities for 4-10 statistical programmers
  • MS in Statistics, Computer Science or a related field with 10+ years of relevant experience. OR BS in Statistics, Computer Science or arelated field with 12+ years of relevant experience.
  • High degree of technical competence and communication ability, both oral and written. Highly competent in SAS programming and Macrodevelopment. Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA andEMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines andrelevant regulatory requirements. A minimum of 2 yrs management experience required.Applicable to California Applicants Only--- The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.This range may be modified in the future.--- The salary range is (minimum: $ 126,500 to maximum: $ 247,000 )--- This job is eligible to participate in our short-term incentive program--- This job is eligible to participate in our long-term incentive programs--- We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
    • • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.AbbVie is an equal opportunity employer including disability/vets. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)Travel: NoJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $126,500 Maximum Salary $247,000

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