Olema Pharmaceuticals Boston , MA 02298
Posted 2 months ago
As the Associate Director of Statistical Programming reporting to the Senior Director of Statistical Programming, you will be accountable for all statistical programming deliverables in adherence to company SOPs and ICH/GCP. You will also help to create and implement Statistical Programming policies and procedures.
This role is based out of our San Francisco, CA office.
Your work will primarily encompass:
Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications
Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.
Ensure timely delivery of all statistical deliverables for each study assigned
Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items
Follow departmental SOPs and processes for operational excellence
Lead statistical programming activities for regulatory submissions following CDISC standards
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan
Take ownership for the completion of SDTM and ADAM specifications for assigned studies
Knowledge:
Bachelor or Master's Degree in Statistics, Life Sciences, Computer Science or related fields
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Strong SAS programming and graphic programming skills
Able to guide the successful completion of major programs and projects
Strong analytical and communication skills
Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology in relevant therapeutic areas
Experience:
8+ years statistical programming experience in biotech/pharmaceutical industry
Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses
Experience with oncology trials is preferred
Experience with R is a plus
Experience with SAS Graphics is a plus
Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus
Experience in management of CROs with respect to statistical programming
Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization
Attributes:
Leadership skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership
Strong verbal and written communication skills
Effectively represent statistical programming in multidisciplinary meetings
Commitment to excellence
Self-motivated and enthusiastic, fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
Have impeccable professional ethics, integrity and judgement
COMP RANGE TEXT:
The base pay range for this position is expected to be $193,000 to $209,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
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Olema Pharmaceuticals