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Engineer Lenk
Aug 28, 2003

Mnogo losho e!
Yeah, a lot of drugs fail. Something like 22 NMEs were approved last year.

I'm a biostatistician at a CRO. We do a lot of clinical trial work for pharma companies of all sizes.

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Engineer Lenk
Aug 28, 2003

Mnogo losho e!

Solkanar512 posted:

If I go to the Biostats, what do I need to know to augment my skills? Do I need to suck it up and get a masters here? What sorts of languages are widely used in this area? Can these sorts of things be self-taught or do I need specific degrees/certs/experience?

Thanks if you guys have advice, I'm just so tired of this place and I've only had two interviews in the past year.

Get a masters degree. There are very few biostatisticians without one. Don't quit ABD on a PhD after forever like I did - it should only take 2-3 years.

If you want to work in industry, learn SAS. If you already have a half-decent CS background this will take remarkably little time. In the academic setting you'll see more R/S+ and some Stata, since R in particular is very good for flexible simulations. I wouldn't bother doing any sort of language certs - just find an assistantship that uses SAS while you're doing your masters. The 9.2 documentation is very good compared to some of the other statistical packages, and pharmaSUG has a ton of papers and examples for more complex stuff.

Engineer Lenk
Aug 28, 2003

Mnogo losho e!

Solkanar512 posted:

So I just have to ask something here. Back in the 1990s/2000s the big drug companies were coming out with drugs all over the place and have since slowed down to almost nothing. Is that because there was some huge breakthrough with computers that enabled a bunch of then low hanging fruit to be picked, or did the management simply ride the wave and forget to make basic investments in R&D and now they're hosed?

I just wonder if smaller companies that invest in R&D (like Seattle's Dendreon) will over the next decade start to overtake the market because they're spending the money or if the issue is something more fundimental.

FDA's also had some high-profile recalls and it's resulting in longer processing on phase III studies and more stringent review.

Heck, I was at a conference a few weeks ago where one of the guys from the FDA was talking about this pending decision (which has since been decided): http://www.medscape.com/viewarticle/743167

He was pretty equivocal about the chances. The DMC stopped the study with a nominal p-value of something like 10^-4 and a really high conditional power, however when they put it against the O'Brien-Fleming it was just in the continuance region.

I'm glad they decided to accept.

Engineer Lenk
Aug 28, 2003

Mnogo losho e!

Sundae posted:

Do any of you guys work in clinical operations?

I'm looking for escape routes, and there's an opening for a scientific communications associate at Lilly. Salary range / scale is the same as my current role, and they're looking for someone with R&D experience, writing skills, a publication background, and a life-sciences background including research experience. Basically a perfect fit in terms of background when I look at the years desired, etc.

"The purpose of the Scientific Communications Associate role is to work with cross-functional, multidisciplinary teams to facilitate external scientific publications (including and not limited to, abstracts, posters, manuscripts and presentations), and/or regulatory documents(including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorizationapplications).
"


What sort of horrible, soul-draining stuff would I be setting myself up for by considering this? Glorified secretary, or reasonable brain-use?

Do you like project management?

Engineer Lenk
Aug 28, 2003

Mnogo losho e!
In my so-far fairly limited pharma experience, clin ops are the project managers. They're the ones who maintain trackers, schedule and run meetings, document decisions that study teams make, keep on top of timelines and act as sort of the central nervous system of a project.

Engineer Lenk
Aug 28, 2003

Mnogo losho e!

Pain of Mind posted:

From what I have seen, masters degrees are almost useless unless you are somehow jumping into a different field with it. I have never seen a position that accepted people with a MS while excluding people with a BS. It might matter straight out of college if both people have 0 experience and are competing for a job, but once you have experience that is all that matters (a masters usually counts for ~ 2 years experience). Jobs can be divided by requiring a PhD or not, and a MS is just as much not a PhD as a BS is.

There are a few pharma jobs where MS is entry level - I haven't seen a biotech or pharma biostatistician position that will take a bachelor's degree.

Ashwat posted:

Anyone have any suggestions for alternate job paths that include people time that I can use my experience for? (I like dealing with people too much, even the crazies :()
Project management? Medical writing?

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Engineer Lenk
Aug 28, 2003

Mnogo losho e!
Were they buying an existing asset? I’ve worked at a biotech with that model, although vetting products for acquisition is a lot of data to work through if they’ve already gone into phase 2.

Rare diseases and oncology can sometimes move pretty fast from dose finding to a combined P2/3 protocol too.

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