Senior Manager, SAS Programme
Works closely with other programmers, biostatisticians, and clinical data managers in supporting the collection, analysis, and reporting of clinical data for phase I-IV clinical development programs.
- Following Study Data Tabulation Model (SDTM) Implementation Guide, develops mapping specifications and complete programming algorithms for Clinical Data Interchange Standards Consortium (CDISC)-compliant SDTM production.
- Following statistical analysis plans and Analysis Data Model (ADaM) standards, develops and performs derivation algorithms for analysis dataset production and performs statistical analyses.
- Produces data listings, summary tables and graphs using SAS software.
- Independently validates data listings, summary tables and graphs.
- Imports and exports SAS data.
- Assists data management group performing data edit checks.
- Reviews Case Report forms (CRF/eCRF) and provides comments.
- Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
- Plays an active role in taking project solutions and generalizing them for the Biostatistics group.
- Interacts with the project statistician, regulatory, medical writing, and/or clinical teams.
- Leads the efforts of programmers on a clinical study
- Takes a leading role in achieving consistency and efficiency across all studies in a therapeutic area
- Evaluates offerings from software vendors and contract service providers
- Other duties as assigned.
Education and Experience
- Bachelor’s degree in Biostatistics/Statistics or related field
- Targeting 8 years progressively responsible experience in clinical statistical programming within pharmaceutical or related industry (biotechnology, medical device, Clinical Research Organization).
- Experience with industry data standards such as SDTM, ADaM, CDISC, or HL7 required.
- Statistical Analysis System (SAS) Certified Base or Advanced Programmer experience is required.
- An equivalent combination of relevant education and applicable job experience may be considered.
- Proven experience in SAS Version 9 programming including base SAS, Access, Macro, Stat, ODS, Graph, and advanced inferential statistics procedures (e.g., proc mixed, proc genmod, proc phreg).
- ISS/ISE project experience is required
- Strong knowledge and/or exposure to statistical graphics software.
- Strong communication skills, teamwork, and attention to detail are crucial. Cross-function communication skills are required.
- Working knowledge of GCP, ICH, 21 CFR part 11, or other international regulations.
- Proven ability to manage multiple projects simultaneously, take initiative and work independently.
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
- Able to make sound decisions and prioritize process and resource decisions based on overall team needs.
- Strong communication and interpersonal skills, and able to create a cooperative team environment.
- Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
- Occasional travel for meetings, conferences and/or other related business.
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. Ability to travel by car or airplane independently and work after hours if required by travel schedule or business issues.
What we offer you (US-Based Employees):
- 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 (US-Based Employees): 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 firstname.lastname@example.org 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.
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