Manager / Senior Manager, Statistical Programming
Company: Heron Therapeutics, Inc.
Location: San Diego
Posted on: June 13, 2021
The Manager / Senior Manager, Statistical Programming will be
responsible for providing statistical programming support for
assigned clinical trials. The incumbent will work closely with
Biostatisticians and Data Managers to create SAS programs for
independently validating selected tables, listings, and figures
produced by programming vendors, for ad-hoc analyses, and to assist
with data cleaning and query generation. This position will also
serve as a contact for programming activities being performed at
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Provides expert support and direction regarding statistical
programming design to ensure timely, targeted, and accurate
reporting and outcomes from assigned projects and ad hoc requests.
Provide SAS programming support for Heron studies.
- Supervise the activities of junior and contract statistical
programmers and help on-board new team members as appropriate.
- Review and approve SAS programming instructions and CDISC/ADaM
specifications and define.xml.
- Manage programming CROs providing oversight for programming
- Lead the development of relevant procedures and processes,
including SOPs, to ensure that statistical programs are properly
documented and validated according to generally recognized industry
and regulatory standards.
- Bachelor's Degree or higher.
- Excellent SAS programming skills including knowledge of
graphical procedures such as SAS macro language, PROC SGPLOT and
the graphics template language (GTL).
- Minimum of 5 years of experience in SAS programming in a
clinical research setting, including academic and/or industry
experience in all phases of clinical research.
- Knowledge of pharmaceutical and regulatory requirements,
procedures, and policies with a minimum of 5 years of
- Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance
documents and policies related to clinical trials operations
- Knowledge of CDISC and ADaM dataset structures and
- Knowledge of all aspects of clinical drug development (Phase
- Excellent computer skills; strong verbal and written
- Ability to work well in a team environment with an open,
engaging, and transparent work style.
- Global perspective and mindset; ability to work effectively
with colleagues from other countries.
- Ability to competently manage multiple competing priorities,
switching priorities quickly as needs change. Must be comfortable
working in a fast-paced environment.
- Demonstrated very high level of technical skill and expertise
as pertains to statistical programming for support and
The above description is intended to describe the general nature
of the job that may include other duties as assumed or assigned; it
is not intended to be all inclusive or limit the duties of the
Heron is an Equal Employment Opportunity/Affirmative Action
Employer: Minority/Female/Disability/Veterans/Sexual Orientation
and Gender Identity.
Keywords: Heron Therapeutics, Inc., San Diego , Manager / Senior Manager, Statistical Programming, Other , San Diego, California
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