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Programming Manager

Employer
Proclinical Staffing
Location
Texas, Dallas, USA
Salary
Highly Competitive Salary
Start date
18 Jan 2023
Closing date
31 Jan 2023

View more

Discipline
Information Technology, Programming, R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Proclinical is seeking a Programming Manager for a leading biotech company located in the US. This position will be in the Statistical Programming team and Clinical Operations organization, responsible for supporting the development of new therapies by performing programming tasks and/or leading a small team to complete various programming efforts within a clinical trial.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

  • Supports and/or leads programming efforts within a clinical study, depending on background and experience
  • As a lead, reviews CRFs for adequacy and consistency
  • Supports the establishment and maintenance of company's SDTM and ADaM database standards
  • As a lead, co-develops analysis related derivation rules, develops data specifications for individual trials and provides guidance to internal programmers or vendors for doing the same
  • Performs database consistency checks on databases delivered by vendor
  • Performs sponsor oversight of programming activities performed by vendor
  • Supports in-house production of tables, figures, and listings by writing programming code following good programming practices
  • Supports in-house QC process by applying the appropriate measures (writing of code, review of code/deliverable)
  • Supports submissions by ensuring programming deliverables are consistent with current agency standards and guidelines
  • Supports resource planning and outsourcing of programming activities.
  • Supports developing and reviewing standard processes and templates.
  • Supports process improvements within the programming department
  • Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
  • Maintains up-to-date knowledge and competencies within relevant therapeutic and professional areas
  • Maintains up-to-date knowledge on relevant regulatory guidelines/requirements
  • Proactively develops and maintains good working relationship with stakeholders and colleagues
  • Participates and represents programming function in teams and meetings
  • Develops, maintains, and ensures proper documentation is available and properly stored (e.g., in eTMF) for programming activities

Skills and Requirements:

  • Completed Bachelor's Degree required or equivalent qualifications (e.g., programming experience and skills in the pharmaceutical industry)
  • At least 3 years of direct experience in programming in the pharmaceutical industry
  • Knowledge, experience, and technical proficiency in the SAS software package
  • Experience working in a global context
  • Proficient in both written and spoken English
  • Oncology experience a plus
  • Programming in R or Python a plus
  • SAS programming
  • Analytical and problem-solving skills
  • Knowledge of the CDISC, SDTM and ADaM data models: the corresponding structures and organizations of the data
  • Contextual understanding of the data
  • Writes efficient, easily maintained and well documented computer programs
  • Is systematic and organized in writing and archiving computer programs as well as other documentation
  • Thorough
  • Proactive, Accountable, and Goal oriented
  • Innovative
  • Team player
  • Good at sharing knowledge
  • Takes responsibility and shows initiative
  • Good communication skills
  • Good planning and coordination skills
  • Ability to flexibly work on multiple tasks without compromise of the quality of the work

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at (+1) 305-929-0913 or p.bonilla@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-PB2

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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