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    Director, Statistical Programming - South San Francisco, United States - Prothena Biosciences

    Prothena Biosciences
    Prothena Biosciences South San Francisco, United States

    3 weeks ago

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    Description

    Position Overview:


    This essential team member will be responsible for managing the statistical programming efforts for projects and studies under Alzheimer's Portfolio, including overseeing the developing, testing, maintaining, validating, and documenting SAS programs.


    Responsibilities:
    To perform this job successfully an individual must be able to perform each essential function satisfactorily:

    • Ensure departmental or functional training plans in place and appropriate
    • Demonstrate excellent leadership skills within department. This includes taking an active role in departmental and company activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate
    • Train and mentor new programmers
    • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
    • Perform vendor qualifications in regards to statistical programming functions and manage CROs regarding programming issues and activities to ensure on time deliverables within budget
    • Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
    • Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications
    • Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)
    • Maintain complete and auditable documentation of all programming activities
    • Manage datasets and output across SAS programs, studies, and indications to ensure consistency
    • Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests
    • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
    • Develop and/or maintain departmental procedures and standards
    • Adhere to departmental and regulatory agency procedures and standards
    • Review CRFs, edit check specifications, and table, figure, and listing mock-ups
    • Manage, generate, and/or review blankCRF, , and documents
    • Works effectively with cross functional groups, study team, and vendors
    • Assist in validation of SAS per 21 CFR Part 11
    • Supervise contract programmers as necessary
    • Assist in creation of table, figure, or listing mockups under supervision of statisticians
    • Other duties as assigned

    Requirements:
    Education and Experience

    • Bachelor's degree or Master's degree in Statistics, Mathematics, or Computer Science or in a related field
    • Minimum of 10 years Biotechnology/Pharmaceutical/CRO industry experience as a statistical programmer
    • Minimum of 5 years' experience as a lead statistical programmer for a clinical study
    • Prior experience managing a statistical programming team required
    • Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
    • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
    • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
    • Excellent communication and interpersonal skills to effectively interface with others

    Competencies and Attributes:

    • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena's culture and values - courageous, imaginative, selfless, and joyful
    • Strong verbal and written communication skills are essential
    • Excellent organization and multi-tasking skills
    • Exceptional interpersonal skills and problem-solving capabilities
    • Proven meeting planning skills
    • Ability to work effectively across a matrix organization
    • Ability to work independently and prioritize with minimal daily instruction
    • Ability to think strategically to improve current processes

    Compensation Overview:
    The anticipated annual salary range for this role is $205,000 to $255,000.

    This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.

    We may ultimately pay more or less than the posted range, and the range may be modified in the future.

    The final salary offered to a successful candidate will be dependent on several factors that may include - but are not limited to - the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

    The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.


    Health & Wellness Benefits, 401(k) and PTO Overview:

    • All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums.
    • Prothena pays the full premium for basic life and disability insurance for all employees.
    • Prothena employees are also eligible to enroll in our Company's 401(k) plan and are always 100% vested in their account balances. The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.
    • New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays - which includes a Company-wide shutdown at the winter holidays.
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