November 9th, 2022 Biometrics

Senior Director, SAS Programming

San Diego, California, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Acadia is looking to bring on a Director, SAS Programming! This person is responsible for providing technical leadership and collaboration with other Statistical Analysis Systems (SAS) programmers, biostatisticians, and clinical data managers in supporting the collection, analysis, and reporting of clinical data for phase I-IV clinical development programs. Ensures accurate development and maintenance of statistical analysis datasets, SAS programming, and output.

Primary Responsibilities:

  • Ensures that the statistical programming team has a well-organized infrastructure and adequate resources to complete projects with high quality and on time.
  • Undertakes the full range of duties relevant to the leadership, management and development of the programming team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
  • Leads statistical programming team by appropriate assignment of responsibilities, defining the scope, and reviewing activities/progress so that projects are delivered on time. Leads decision-making as to what programs should be done internally vs. outsourced.
  • Performs vendor qualifications in regard to statistical programming functions and handles CROs regarding programming issues and activities to ensure timely deliverables within budget.
  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to align with regulatory requirements, SOPs, and work practices
  • Develops, validates, and maintains individual and integrated databases of relevant clinical trial data for a given compound.
  • Ensures SAS programming work is consistent with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
  • Arranges training opportunities.

Qualifications:

  • Bachelor’s degree in (bio) statistics or related field. An equivalent combination of relevant education and applicable job experience may be considered.
  • Master's degree preferred. Statistical Analysis System (SAS) Certified Base or Advanced Programmer experience is required.
  • Desired 10 years of progressively responsible experience in clinical statistical programming within the pharmaceutical or related industry (biotechnology, medical device, Clinical Research Organization (CRO)) with a focus on SAS programming and 6 years in a leadership role and Pharmaceutical industry experience preferred.
  • Broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process.
  • Experience includes leading SAS programmers on projects that have agreed-upon deliverables on time, and prior guidance of lower level or less experienced staff.
  • In-depth experience in SAS programming including base SAS, Access, Macro, Stat, ODS, Graph, and advanced inferential statistics procedures (e.g., proc mixed, proc genmod, proc phreg).
  • Experience with industry data standards such as SDTM, AdAM, CDISC, or HL7 required.
  • Knowledge of statistical graphics software is required.
  • Demonstrated contribution to analysis of clinical trials and/or clinical research projects, and/or participation in preparation of academic manuscripts or other written summaries of analysis results, thorough experience with the drug development process.
  • Ability to consistently demonstrate leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects.
  • Excellent interpersonal communication and networking skills with the ability to build cross-functional bridges.
  • Working knowledge of GCP, ICH, 21 CFR part 11, or other international regulations.
  • Experience in vendor contract and relationship management to assure sufficient due diligence and risk analysis. Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
  • Employee must be fully vaccinated against Covid-19 in accordance with our policy.
  • Must reside in the United States.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds. Employee must be fully vaccinated against Covid-19 in accordance with our policy and in order to meet any independent vaccination requirements that our clients and client facilities may have.

#LI-Hybrid #LI-MH1

 

 

What we offer you:

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 401(k) Plan with a fully vested company match 1:1 up to 5%
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in
  • 15+ vacation days
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

EEO Statement:

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.