Associate programmer job description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients, and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.

SUMMARY/JOB PURPOSE:

Leads statistical programming activities at the study or project level. Uses statistical software (mainly SAS) to create and maintain macros, listings, tabulations, graphical summaries, and formal statistical estimates and tests. Creates datasets in a standard format (i.e., SDTM, ADaM), assesses quality of dataset programs, and develops automated analysis tools where appropriate. Develops programs to assist with data review such as edit checks and custom listings. May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

As the lead programmer, responsible for helping to identify when additional programming resources are needed for a project, communicating with their supervisor to arrange for those resources, and coordinating and overseeing other statistical programmers' work on the project as needed. Follow SDLC (Software Development Lifecycle) to create new global macros and standard programs to meet department needs. Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries, Publication requests and adhoc analyses. As the lead or support programmer on studies, work with clinical data management staff and biostatisticians to coordinate and schedule data transfers and the delivery of required outputs. Oversee the development of datasets in ODS, SDTM, & ADaM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists. Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs). Must be able to program defensively, check results, and consistently produce accurate output. Adhere to FDA regulations regarding training records, guidelines, and SOPs. Adhere to company SOPs/WIs and department guidelines. Produce study datasets and programs that will help meet CDISC standards. Support ad-hoc requests as needed. Work on multiple tasks at the same time and prioritize tasks to meet business needs. Trouble-shoot technical and project issues. Help with the infrastructure development of the department. Assist team to ensure timelines for the study and/or project are met. Assist with training new employees and contractors, in particular on macros, study specifics and departmental programming conventions and standards. Communicate with outside departments and/or groups. Meet timelines on a regular basis.

SUPERVISORY RESPONSIBILITIES:

There will not be any supervisory responsibilities and direct reports. Oversee support programmers and CROs as the lead programmer.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

BS/BA degree in related discipline and a minimum of 10 years of related experience; or MS/MA degree in related discipline and a minimum of 8 years of related experience; or PhD in related discipline and a minimum of 5-8 years of related experience; or Equivalent combination of education and experience. May require certification in assigned area.

Experience

At least 12 years experience in Pharmaceutical/Biotech programming. Demonstrated proficiency in SAS/Base, SAS/Stat, and SAS/Macros. UNIX, CDISC, and SAS graphics experience desirable. Experience with Oncology clinical trials a plus.
• NDA submission experience a plus.

Knowledge/Skills:

Has extensive experience in relevant industry/profession and area of specialization. Uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Ability to communicate verbally and in writing in a clear and timely manner. Leads or manages the work of others by providing guidance to teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing. Performs a variety of complicated tasks with a wide degree of creativity and latitude. Has complete understanding and wide application of technical principles, theories, concepts and techniques. Has good general knowledge of other related disciplines. Applies strong analytical and business communication skills.

WORKING CONDITIONS/JOB COMPLEXITY:

• This is an office-based role and will be required to be onsite.

Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results. Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways. Networks with key contacts outside own area of expertise.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!


DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.


We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

**JOB SUMMARY**

+ This role is site based at one of the listed locations.

+ This role is a hands on statistical programmer supporting study and asset teams in the delivery of less complex statistical programming deliverables.

+ Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures, and qc work for which they are responsible.

+ Ensures adherence to high quality programming standards in their daily work.

**JOB RESPONSIBILITIES**

+ Accountable for their assigned work in the programming space supporting the programming leads for a particular study or asset deliverable.

+ Ensures appropriate documentation and QC documentation for their deliverables.

+ May provide supportive QC work for other programmers deliverables.

+ Works with programming leads to ensure clear specifications for their programmed deliverables are in place.

+ Will be learning in the space of programming and data standards.

**QUALIFICATIONS / SKILLS**

+ Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.

+ At least 1 year relevant experience in SAS programming and knowledge of clinical trials.

+ Statistical Programming and SAS hand-on experience.

+ Working knowledge of clinical data.

+ Strong written and oral communication skills, and time management skills.

+ Proven ability to manage timelines.

+ CDISC experience desirable.

Other Job Details:

+ Eligible for Relocation Package: NO

+ Eligible for Employee Referral Bonus: YES

+ \#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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